Glucosamine No Better than Placebo for Hip Osteoarthritis

Glucosamine sulfate provides no benefit in the treatment of hip osteoarthritis, according to a randomized trial in Annals of Internal Medicine.

The study, conducted in the Netherlands, randomized about 200 patients to glucosamine or placebo for 2 years. No clinically significant effect was found on pain, joint function, or joint space narrowing.

The authors note that a 2005 Cochrane review of 15 studies found a moderate effect of glucosamine on pain. However, the latest results "suggest that glucosamine sulfate is not an effective therapy for patients with hip osteoarthritis."

An editorialist wrote that despite glucosamine's wide use, "its place in the treatment of osteoarthritis is still being debated."

Annals of Internal Medicine article (Free abstract; full text requires subscription)

Annals of Internal Medicine editorial (Subscription required)

Guidelines Revised for Management of Type 2 Diabetes Mellitus

November 30, 2007 — The American Diabetes Association and the European Association for the Study of Diabetes have issued a consensus statement on the management of hyperglycemia in type 2 diabetes mellitus. This consensus algorithm for the initiation and update regarding the thiazolidinediones was published in the November 27 Online First issue of Diabetologia.

"New information suggests additional hazards associated with the use of either thiazolidinedione, and rosiglitazone in particular may result in an increased frequency of myocardial infarctions," write David M. Nathan, MD, from the Diabetes Center, Massachusetts General Hospital, Harvard Medical School, in Boston, Massachusetts , and colleagues. "We therefore recommend greater caution in using the thiazolidinediones, especially in patients at risk of, or with, CHF [congestive heart failure]."

Approximately 1 year ago, the American Diabetes Association and the European Association for the Study of Diabetes commissioned development of an evidence-based, consensus algorithm for the management of type 2 diabetes mellitus, which was designed to help clinicians choose the most appropriate treatment regimens from the expanding armamentarium of available drugs.

The guidelines authors note that newly approved medications and new data from clinical trials and other studies should be considered in the management of type 2 diabetes, thereby warranting an update of the algorithm. The present update mainly focuses on recent understanding of the advantages and disadvantages of the thiazolidinediones.

The guidelines also now include the dipeptidylpeptidase-4 inhibitor sitagliptin as a management option in the revised algorithm, noting that this agent was not yet approved by the US Food and Drug Administration (FDA) when the original algorithm was issued. Comments concerning sitagliptin are that expected percentage decrease in hemoglobin A1c (HbA1c) levels is 0.5% to 0.8%. Advantages of sitagliptin are that it is weight neutral, but disadvantages are that there is scant clinical experience with the drug, and it is expensive.

The revised guidelines continue to support the major features of the original algorithm, including the need for tight glycemic control within, or as close to, the nondiabetic range without compromising safety; beginning lifestyle interventions and treatment with metformin at the time of diagnosis; rapidly adding medications and changing to new regimens when target glycemia is not reached; and adding insulin treatment for patients not achieving target HbA1c levels.

"We are mindful of the importance of not changing this consensus guideline in the absence of definitive or compelling new data," the guidelines authors write. "Future updates are planned to consider further revisions of the algorithm, guided by the evidence base and clinical experience with the newer classes of glucose-lowering medications."

In the original consensus algorithm, the thiazolidinediones, insulin, and sulfonylurea were 3 possible options that should be added to metformin and lifestyle intervention if target HbA1c levels (<>

However, another recent meta-analysis, reviewing virtually the same data, showed that neither rosiglitazone nor pioglitazone was associated with a significantly increased risk for cardiovascular death.

The Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) study was designed specifically to evaluate cardiovascular outcomes associated with rosiglitazone therapy. Although an interim analysis of RECORD showed an increased risk for CHF associated with rosiglitazone (hazard ratio [HR], 2.15; 95% confidence interval [CI], 1.30 - 3.57), no statistically significant effects of rosiglitazone on myocardial infarction were observed (HR, 1.17; 95% CI, 0.75 - 1.82).

A meta-analysis of clinical trial data concerning the risk for cardiovascular disease associated with use of pioglitazone actually suggested that this drug may have a protective effect. However, both pioglitazone and rosiglitazone have been linked to an increased risk (approximately double) for fluid retention and CHF, which has resulted in a stronger black box warning in the prescribing information for the thiazolidinediones.

Especially in women, both pioglitazone and rosiglitazone have been associated with increased risk for fractures, mostly in the distal extremities (forearm, hand, wrist, foot, ankle, fibula, or tibia), where osteoporotic fractures do not typically occur.

"At this time, we do not view as definitive the clinical trial data regarding increased or decreased risk of myocardial infarctions with rosiglitazone or pioglitazone, respectively," the guidelines authors conclude. "Nor do we think that the increased risk of CHF or fractures with either of the available thiazolidinediones is of a magnitude to warrant their removal as one of the possible second-step medications in our algorithm, given that they cause hypoglycaemia less frequently than other second-step drugs. On the other hand, we do believe that the weight of the new information outlined above should prompt clinicians to consider more carefully whether to use this class of drugs vs insulin or sulfonylureas as the second step in the algorithm."

The guidelines further note that there may be clinically important differences between pioglitazone and rosiglitazone and that maintaining both thiazolidinediones in the current algorithm represents a balance between the need for multiple options to treat a challenging and progressively serious disease such as diabetes and the recent unfavorable data.

Some of the guidelines authors have disclosed various financial relationships with the University of North Carolina, Sanofi-Aventis, GlaxoSmithKline (maker of rosiglitazone), Pfizer, Amylin, Bristol-Myers Squibb, Hoffman-LaRoche, Eli Lilly, NovoNordisk, Merck (maker of sitagliptin), Novartis, AstraZeneca, Merck Sharp & Dohme, Roche, Servier, Boehringer Ingelheim, Takeda (maker of pioglitazone), Johnson & Johnson, and Smiths Medical.

Diabetologia. Published online November 27, 2007.

Clinical Context

The American Diabetes Association and the European Association for the Study of Diabetes commissioned development approximately 1 year ago of an evidence-based consensus algorithm for the management of type 2 diabetes. The purpose of this algorithm was to facilitate choice of the most appropriate treatment regimens from the ever-increasing options of drugs approved for the treatment of type 2 diabetes.

Recently approved medications and new evidence from clinical and other studies should be considered in the management of type 2 diabetes. The current update of the original algorithm highlights recent evidence concerning the advantages and disadvantages of the thiazolidinediones and now includes sitagliptin, which was recently approved for treatment of type 2 diabetes.

Study Highlights

• New data suggest potential harms associated with the use of either pioglitazone or rosiglitazone, more so with the latter drug, in increased frequency of myocardial infarctions.
• Therefore, the revised guidelines recommend greater caution in use of the thiazolidinediones, especially in patients at risk for, or with, CHF.
• Recent meta-analyses suggest a 30% to 40% relative increase in the risk for myocardial infarctions with use of rosiglitazone, but the underlying data are not thought to be conclusive. Another recent meta-analysis, reviewing virtually the same data, showed that neither rosiglitazone nor pioglitazone was associated with a significantly increased risk for cardiovascular death.
• An interim analysis of RECORD showed an increased risk for CHF associated with rosiglitazone (HR, 2.15; 95% CI, 1.30 - 3.57) but no statistically significant effects of rosiglitazone on myocardial infarction (HR, 1.17; 95% CI, 0.75 - 1.82).
• A meta-analysis of clinical trial data suggested that pioglitazone may actually have a protective effect against cardiovascular disease. However, both pioglitazone and rosiglitazone have been linked to approximately double the risk for fluid retention and CHF, resulting in a stronger black box warning.
• Especially in women, both pioglitazone and rosiglitazone have been associated with increased risk for fractures, mostly in the distal extremities (forearm, hand, wrist, foot, ankle, fibula, or tibia), where osteoporotic fractures do not typically occur.
• The guidelines authors conclude that the evidence of increased risk for CHF or fractures with the thiazolidinediones is insufficient to warrant their removal as one of the possible second-step medications in the algorithm because they cause hypoglycemia less often than do other second-step drugs.
• However, the authors suggest that clinicians consider more carefully whether to use this class of drugs vs insulin or sulfonylureas as the second step in the algorithm. There may be clinically important differences between pioglitazone and rosiglitazone.
• The revised guidelines continue to support the major features of the original algorithm, including the need for tight glycemic control within, or as close to, the nondiabetic range without compromising safety; beginning lifestyle interventions and treatment with metformin at the time of diagnosis; rapidly adding medications and changing to new regimens when target glycemia is not reached; and adding insulin treatment for patients not achieving target HbA1c levels.
• In the original consensus algorithm, the thiazolidinediones, insulin, and sulfonylurea were 3 possible options that should be added to metformin and lifestyle intervention if target HbA1c levels (<>
• The revised algorithm now also includes sitagliptin, a dipeptidylpeptidase-4 inhibitor that was only recently FDA approved, as a management option.
• With use of sitagliptin, expected percentage decrease in HbA1c levels is 0.5% to 0.8%. Advantages of sitagliptin are that it is weight neutral, but disadvantages are that there is limited clinical experience with the drug, and it is expensive.

Pearls for Practice

Recent evidence suggests adverse outcomes may be associated with use of the thiazolidinediones in patients with type 2 diabetes who have, or are at risk for, CHF. Although the underlying data are not thought to be conclusive, clinicians are still warned to use extra caution when considering use of rosiglitazone, which has been associated with increased risk for myocardial infarction. Especially in women, both pioglitazone and rosiglitazone have been associated with increased risk for fractures, mostly in the distal extremities.

The guidelines also now include the recently approved dipeptidylpeptidase-4 inhibitor sitagliptin as a management option for treating type 2 diabetes. Expected percentage decrease in HbA1c levels with sitagliptin is 0.5% to 0.8%. Advantages of sitagliptin are that it is weight neutral, but disadvantages are that there is limited clinical experience with the drug, and it is expensive.

         

Gracias Dr. José Manuel Ferrer Guerra

American Diabetes Association Updates Guidelines for Medical Nutrition Therapy

News Author: Laurie Barclay, MD

CME Author: Charles Vega, MD

December 28, 2007 — The American Diabetes Association (ADA) has updated its guidelines regarding medical nutrition therapy (MNT) to prevent diabetes, manage existing diabetes, and prevent or slow the rate of development of diabetes complications. The revised position statement, which is published in the January issue of Diabetes Care, updates those from 2002 and 2004, presenting evidence-based data published since 2000 and grading of recommendations according to the level of evidence available, based on the ADA evidence-grading system.

"The goal of these recommendations is to make people with diabetes and health care providers aware of beneficial nutrition interventions," write John P. Bantle, and colleagues from the ADA. "This requires the use of the best available scientific evidence while taking into account treatment goals, strategies to attain such goals, and changes individuals with diabetes are willing and able to make. Achieving nutrition-related goals requires a coordinated team effort that includes the person with diabetes and involves him or her in the decision-making process."

Because overweight and obesity are closely associated with development of diabetes, the position statement highlights this area of MNT. The US Department of Health and Human Services (HHS) recommends primary prevention interventions to delay or prevent the development of diabetes, using public health measures to decrease the prevalence of obesity and implementing MNT in persons with prediabetes. Secondary and tertiary prevention measures recommended by HHS include MNT for patients with diabetes to prevent (secondary) or control (tertiary) diabetes complications.

In addition to listing major nutritional recommendations and interventions for diabetes, the updated position statement stresses the importance of monitoring metabolic parameters, including glucose and glycated hemoglobin levels, lipids, blood pressure, body weight, and renal function, during therapy. Such monitoring will help evaluate the need for changes in MNT and thereby optimize outcomes. The authors note that many aspects of MNT require additional research.

Some of the specific recommendations include the following:

• Individuals with prediabetes or diabetes should receive individualized MNT, preferably administered by a registered dietitian knowledgeable about the components of diabetes MNT (B).
• Nutrition counseling should be tailored to the personal needs of the individual with prediabetes or diabetes and his or her willingness and ability to make changes (E).
• Modest weight loss in overweight and obese insulin-resistant individuals has been shown to improve insulin resistance and is therefore recommended for all such individuals who have or are at risk for diabetes (A).
• In the short-term (up to 1 year), either low-carbohydrate or low-fat, energy-restricted diets may be effective for weight loss (A).
• Patients receiving low-carbohydrate diets should undergo monitoring of lipid profiles, renal function, and protein intake (in patients with nephropathy), and have adjustment of hypoglycemic therapy as needed (E).
• Physical activity and behavior modification aid in weight loss and are most helpful in maintaining weight loss (B).
• When combined with lifestyle modification, weight loss medications may help achieve a 5% to 10% weight loss and may be considered for overweight and obese individuals with type 2 diabetes (B).
• For some patients with type 2 diabetes and a body mass index of 35 kg/m2 or more, bariatric surgery can markedly improve glycemia (B).
• Primary prevention for individuals at high risk of developing type 2 diabetes should include structured programs targeting lifestyle changes, with dietary strategies of decreasing energy and dietary fat intakes. Goals should include moderate weight loss (7% body weight), regular physical activity (150 minutes/week) (A), dietary fiber intake of 14 g/1000 kcal, and whole grains comprising half of total grain intake (B).
• Intake of low-glycemic index foods that are rich in fiber and other vital nutrients should be encouraged (E), both for the general population and for those with diabetes.
• Data do not support recommending alcohol consumption to individuals at risk for diabetes (B).
• No nutritional recommendations exist to prevent type 1 diabetes (E).
• Secondary prevention, or controlling diabetes, should include a healthy dietary pattern emphasizing carbohydrate from fruits, vegetables, whole grains, legumes, and low-fat milk (B).
• A key strategy for achieving glycemic control is to monitor carbohydrate by counting, exchanges, or experienced-based estimation (A). Use of glycemic index and load may be modestly beneficial vs considering only total carbohydrate (B).
• Sucrose-containing foods should be limited but can be substituted for other carbohydrates or covered with insulin or other glucose-lowering medications (A). Glucose alcohols and nonnutritive sweeteners are safe within daily US Food and Drug Administration intake levels (A).
• Saturated fat should be limited to less than 7% of total energy (A), and trans fat should be minimized (E). In individuals with diabetes, dietary cholesterol should not exceed 200 mg/day (E).
• At least 2 servings of fish per week (except for commercially fried fish) are recommended for n-3 polyunsaturated fatty acids (B).
• Protein should not be used to treat acute or prevent nighttime hypoglycemia (A). High-protein diets are not recommended for weight loss (E).
• If adults with diabetes choose to use alcohol, intake should be restricted to 1 drink per day or less for women and 2 drinks per day or less for men (E) and consumed with food (E).

Other topics covered in this statement regarding secondary prevention include micronutrients in diabetes management; and nutritional interventions for type 1 and type 2 diabetes, pregnancy and lactation with diabetes, and older adults with diabetes.

Application of MNT to tertiary prevention, or treating and controlling diabetes complications, may be useful for microvascular complications, treatment and management of cardiovascular risk, management of hypoglycemia, management of acute illness, management of patients with diabetes in acute healthcare facilities, and management of patients with diabetes in long-term care facilities.

"MNT is important in preventing diabetes, managing existing diabetes, and preventing, or at least slowing, the rate of development of diabetes complications," the authors conclude. "It is recommended that a registered dietitian, knowledgeable and skilled in MNT, be the team member who plays the leading role in providing nutrition care. However, it is important that all team members, including physicians and nurses, be knowledgeable about MNT and support its implementation."

Diabetes Care. 2008;31(Suppl 1):S61-S78.

Clinical Context

Appropriate nutrition is one of the cornerstones of management for both type 1 and type 2 diabetes, and a focused dietary program can have significant effects on glycemic control. Previous research has found that MNT can reduce glycated hemoglobin levels by approximately 1% among patients with type 1 diabetes and by 1% to 2% among patients with type 2 diabetes.

The ADA last published recommendations regarding MNT in 2002, which were then slightly modified in 2004. The current recommendations update these previous guidelines with an emphasis on recent research findings.

Study Highlights

• Dietary advice is best provided by a registered dietician who is familiar with components of diabetes MNT.
• Weight loss medications may be considered for overweight or obese patients with type 2 diabetes, as these medications may promote a weight loss of 5% to 10% of body weight when combined with lifestyle interventions.
• Bariatric surgery may be considered for patients with diabetes whose body mass index exceeds 35 kg/m2. Some research has demonstrated that this surgery can lead to resolution of type 2 diabetes in more than three fourths of patients treated.
• Patients at high risk of developing type 2 diabetes should be recommended to begin a lifestyle program that includes physical activity for a minimum of 150 minutes per week and consumption of 14 g of dietary fiber for every 1000 kcal of diet. These patients with obesity should set a target of losing approximately 7% of body weight.
• There is not conclusive evidence that low-glycemic diets reduce the risk for diabetes, although these diets may be helpful because of their high fiber content. These diets should not be routinely recommended to patients with prediabetes.
• Moderate alcohol use may reduce the risk for diabetes, although clinicians should not recommend alcohol use for this purpose.
• Among patients consuming a high-glycemic diet, converting to a low-glycemic index diet can provide some modest benefit in postprandial hyperglycemia.
• Glucose alcohols and nonnutritive sweeteners may be used in moderation by patients with diabetes.
• Saturated fat should not comprise more than 7% of total energy per day, and dietary cholesterol intake should be less than 200 mg per day.
• There is insufficient evidence to recommend that patients with diabetes should consume a higher amount of protein vs other adults without diabetes. Foods rich in protein should not be used to treat hypoglycemia.
• The authors recommend against high-protein diets for weight loss among patients with diabetes. The benefits of these diets for body mass may be short-lived, and there are limited data on long-term renal complications associated with high-protein diets.
• Routine use of dietary supplements or vitamins is not recommended for patients with diabetes. However, older adults with reduced energy intake may benefit from a daily multivitamin.
• Protein intake should not exceed 1 g per kg of body weight per day among patients with early chronic kidney disease, and this upper limit of intake should decrease to 0.8 g/kg of body weight per day in the later stage of kidney disease.
• Hypoglycemia should be treated with 15 to 20 g of glucose, or a similar carbohydrate equivalent. The response to this treatment should occur between 10 and 20 minutes.

Pearls for Practice

• Previous research has suggested that MNT can reduce glycated hemoglobin levels by approximately 1% for patients with type 1 diabetes and 1% to 2% for patients with type 2 diabetes.
• The current guidelines do not recommend low-glycemic index or high-protein diets for the routine treatment of patients with diabetes. Moreover, most patients with diabetes should not routinely receive supplements or vitamins.

         

Gracias Dr. José Manuel Ferrer Guerra!!

Dietary Soy May Improve Features of Metabolic Syndrome in Postmenopausal Women

News Author: Laurie Barclay, MD

CME Author: Penny Murata, MD

Short-term soy-nut consumption improves glycemic control and lipid profiles in postmenopausal women with metabolic syndrome, according to the results of a small randomized crossover trial reported in the March issue of the American Journal of Clinical Nutrition.

"Little evidence exists regarding the effects of soy consumption on the metabolic syndrome in humans," write Leila Azadbakht, MSC, from the Shaheed Beheshti University of Medical Sciences in Tehran, Iran, and colleagues. "Soy consumption could reduce the risk of the metabolic syndrome through its beneficial components, including complex carbohydrates, unsaturated fatty acids, vegetable protein, soluble fiber, oligosaccharides, vitamins, minerals, inositol-derived substances such as lipintol and pinitol, and phytoestrogens, particularly the isoflavones genistein, diadzein, and glycitein. However, the amount and kind of these components may vary in different kinds of soy products; ie, textured soy-protein or soy-nut."

In a crossover design, 42 postmenopausal women with metabolic syndrome were randomized to consume a control diet (Dietary Approaches to Stop Hypertension [DASH]), a soy-protein diet, or a soy-nut diet, each for 8 weeks. Red meat in the DASH period was replaced by soy protein in the soy-protein period and by soy nut in the soy-nut period.

The homeostasis model of assessment–insulin resistance (HOMA-IR) score was significantly decreased with the soy-nut regimen compared with the soy-protein (difference in percentage change, -7.4 ± 0.8; P < .01) or control (-12.9 ± 0.9; P < .01) diets.

Fasting plasma glucose level was also reduced more significantly during consumption of the soy-nut diet compared with the soy-protein (-5.3% ± 0.5%; P < .01) or control diet (-5.1% ± 0.6%; P < .01). Low-density lipoprotein (LDL) cholesterol level was decreased more during the soy-nut diet than during the soy-protein diet (-5.0% ± 0.6%; P < .01) or the control diet (-9.5% ± 0.6%; P < .01). Compared with the control diet, soy-nut but not soy-protein consumption significantly reduced serum C-peptide concentrations (-8.0 ± 2.1; P < .01).

Study limitations include failure to evaluate the effects of soy protein or soy nut according to estrogen-receptor genotype or based on "equol producer" or "equol nonproducer" status.

"Short-term soy-nut consumption improved glycemic control and lipid profiles in postmenopausal women with the metabolic syndrome," the authors write. "Soy as a replacement for red meat in a DASH eating plan had beneficial effects on features of the metabolic syndrome, soy-nut being more effective than soy-protein."

The National Nutrition and Food Technology Research Institute, Shaheed Beheshti University of Medical Sciences supported this study. None of the authors have disclosed any financial relationships.

Am J Clin Nutr. 2007;85:735-741.

Clinical Context

Soy intake has been found to have beneficial effects on lipid levels, for example, as reported in a meta-analysis by Anderson and colleagues in the August 1995 issue of The New England Journal of Medicine. An animal-based study by Dyrskog and colleagues in the October 2005 issue of Metabolism noted a soy-based diet had preventive effects for metabolic syndrome, but the effects of a soy-based diet in humans with metabolic syndrome are not clear.

This randomized, crossover study compares the effects of soy-nut and soy-protein diets on metabolic syndrome components, including plasma lipids, lipoproteins, insulin resistance, and glycemic control in postmenopausal women with metabolic syndrome.

Study Highlights

• 120 women in Tehran were screened for study inclusion if they were postmenopausal, defined by no menstruation for more than 1 year and correlation of follicle-stimulating hormone, luteinizing hormone, testosterone, and estradiol results.
• 42 women who had at least 3 features of metabolic syndrome were enrolled and completed the study.
• Metabolic syndrome was defined per Adult Treatment Panel III guidelines: abdominal adiposity; serum high-density lipoprotein (HDL) cholesterol level less than 50 mg/dL; triglyceride level at least 150 mg/dL; systolic blood pressure at least 130 mm Hg and diastolic blood pressure at least 85 mm Hg; and glucose level at least 110 mg/dL.
• Exclusion criteria included secondary cause of hyperglycemia, estrogen therapy up to 6 months prior, insulin or oral hypoglycemic medication, untreated hypothyroidism, smoking, kidney or liver disease, and breast malignancy.
• After 3 weeks of usual diet, all women were randomly assigned to receive 1 of 3 diets for 8 weeks in random order with 4-week washout periods between diet regimens.
• Control diet consisted of 50% to 60% carbohydrate, 15% to 20% protein, and less than 30% fat; 1 serving of red meat; high intake of fruit, vegetables, whole grains, and low-fat dairy products; low intake of total fat, saturated fat, cholesterol, refined grains, and sweets; and sodium intake of 2400 mg/day.
• Soy-nut diet replaced red meat serving with 30 g of soy nut; soy isoflavones were 102 mg/day.
• Soy-protein diet replaced red meat serving with 30 g of soy protein; soy isoflavones were 84 mg/day.
• Women received instruction on meal preparation and contacted nutritionist daily.
• At 45- to 60-minute study visits conducted every 2 weeks, 3-day diet records and physical activity records were reviewed.
• Patient adherence was assessed by monthly review of diet records and attendance at monthly group discussions.
• Baseline data obtained at the beginning of each diet were similar: weight, waist circumference, blood pressure, fasting blood glucose, triacylglycerols, and levels of HDL cholesterol, LDL cholesterol, total cholesterol, fasting insulin, C-peptide, apolipoprotein AI, and apolipoprotein B100 (apoB-100) and HOMA-IR.
• Soy-protein diet vs control diet significantly improved levels of total cholesterol, LDL cholesterol, fasting insulin, and apoB-100 and HOMA-IR.
• Soy-nut vs control diet also significantly improved levels of total cholesterol, LDL cholesterol, fasting insulin, and apoB-100 and HOMA-IR, in addition to fasting glucose and C-peptide levels.
• HOMA-IR score decreased more on soy-nut diet vs soy-protein diet (difference in percentage change, -7.4; P < .01) vs control diet (-12.9; P < .01).
• Fasting plasma glucose level decreased more on soy-nut diet vs soy-protein diet (-5.3%; P < .01) vs control (-5.1; P < .01).
• LDL cholesterol level decreased more on soy-nut diet vs soy-protein diet (-5.0%; P < .01) vs control (-9.5%; P < .01).
• C-peptide decreased more on soy-nut diet vs control (-8.0; P < .01); soy-protein diet had no significant effect.
• Systolic and diastolic blood pressures did not change significantly.
• Activity level did not change during study.
• 1 person reported bloated feeling during soy-protein diet.
• Order of diet regimen did not affect results.
• Plasma phytoestrogen increased on soy-nut diet (by 64%; P < .01) and on soy-protein diet (48%; P < .01) vs control diet.

Pearls for Practice

In postmenopausal women with metabolic syndrome, intake of soy nuts improved HOMA-IR score and reduced fasting plasma glucose and serum C-peptide levels more than intake of soy protein.

In postmenopausal women with metabolic syndrome, intake of soy nuts decreased LDL cholesterol, total cholesterol, and apoB-100 levels more than intake of soy protein.

         

Gracias Dr. José Manuel Ferrer Guerra!