Effects of Peanut and Peanut Butter Consumption on Blood Lipids and Glycemic Control in Adults With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
National Peanut Board
Information provided by (Responsible Party):
Joan Sabate,DrPH, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT00937222
First received: July 8, 2009
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Dietary Supplement: Peanuts and peanut butter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Peanut and Peanut Butter Consumption on Blood Lipids and Glycemic Control in Adults Ith Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • The primary outcome measure is HDL-C [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum lipids, glucose, HbA1c, anthropometrics and blood pressure [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Peanuts and peanut butter
    Peanuts and peanut butter
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of a medical diagnosis of diabetes for at least 6 months
  • HbA1c < 9%
  • Age greater than 18 years
  • Resident of Loma Linda, California area

Exclusion Criteria:

  • Allergy to peanuts
  • Smokers
  • History of irritable bowel disease or diverticulitis
  • Statin therapy (unless stable statin dose for 3 months)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937222

Locations
United States, California
Loma Linda University Medical Center Diabetes Treatment Center
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Loma Linda University
National Peanut Board
Investigators
Principal Investigator: Joan Sabaté, MD, DrPh Chair, Department of Nutrition
Study Director: Michelle Wien, DrPH Assistant Professor, Department of Nutrition
  More Information

Additional Information:
No publications provided by Loma Linda University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joan Sabate,DrPH, MD, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT00937222     History of Changes
Other Study ID Numbers: 59049
Study First Received: July 8, 2009
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
diabetes
cholesterol
peanuts
peanut butter
dietary intervention
HDL cholesterol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014