An interventional study of Peanuts and peanut butter in Type 2 Diabetes, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-20.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
Peanuts and peanut butter contain high levels of monounsaturated fat (MUFA), arginine, fiber, phytosterols, resveratrol and vitamin E that have the potential to reduce cardiovascular disease (CVD) risk through improved blood glucose control and favorable modification of blood lipids. When substituted for saturated fat in the diet, MUFA may have important metabolic benefits for persons with diabetes. Therefore, the investigators propose to study the effects of a peanut and peanut butter-enriched diet on markers of CVD risk factors in free-living adults with diabetes residing in Southern California. This study's primary clinical outcome will be high-density lipoprotein (HDL) - cholesterol. Secondary outcomes will include additional serum lipids (total cholesterol, low-density lipoprotein (LDL) - cholesterol and triacylglycerol), glucose, HbA1c, and anthropometry (body weight, body composition and waist circumference). This study will provide vital information about the role of peanuts and peanut butter in modulating blood glucose homeostasis and CVD risk factors among adults with diabetes.
This will be a parallel randomized controlled intervention study on free-living adults with diabetes. The study duration will be 6 months. Participants will be randomized to receive one of two dietary approaches (moderate fat, control; and, moderate fat inclusive of 32 g peanuts or 2 Tbsp. peanut butter per day, intervention) to an ADA meal plan targeting a profile of 35% fat, 45% CHO and 20% protein. A supply of peanuts and peanut butter from the National Peanut Board will be provided to participants assigned to the intervention group at clinic visits. The peanuts and peanut butter will be consumed as part of the participant's customary meals and snacks. In light of ADA's prior recommendation to derive 60 to 70% of energy intake from CHO and MUFA, the peanuts and peanut butter will provide an enhanced proportion of energy from MUFA (total fat content of peanuts by compositional weight is 22% and 52% of the total fat is MUFA).
An experienced Registered Dietitian and Certified Diabetes Educator will oversee the dietary advice provided to each of the two groups. All participants will be provided with an individualized portion-controlled meal plan using the ADA food exchange lists and possibly modified fat instruction on fatty acid considerations and inclusion of peanuts and peanut butter. Dietary compliance, especially the intake of peanuts and peanut butter, will be measured by six 24-hour recalls without notice (telephone interview by a dietitian on what was consumed the previous day). Participants will be requested to maintain their activities and other lifestyle habits and to record in diaries provided to them any signs of illness, medications used, and any deviation from their prescribed diet. The investigators will examine diaries at the clinic visits. No major deviations from the protocol will be tolerated.
Less than 100 ml of blood will be drawn from each participant at baseline (week 0), week 12 and week 24. All blood drawings will be performed at Loma Linda University Medical Center. Participants will report to the laboratory on the assigned days after fasting for a minimum of 12 hours. Body weight and body composition measurements (percent body fat, fat free mass, total body water) will be obtained at each clinic visit using an internally calibrated segmental bioelectrical impedance analysis device (Tanita®, Arlington Heights, IL).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Peanuts and peanut butter
The primary outcome measure is HDL-C
Time frame: 12 weeks and 24 weeks
Serum lipids, glucose, HbA1c, anthropometrics and blood pressure
Time frame: 12 weeks and 24 weeks
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Loma Linda University