Effects of Peanut and Peanut Butter Consumption on Blood Lipids and Glycemic Control in Adults With Type 2 Diabetes
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Jun 2009
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 8, 2009
CompletedFirst Posted
Study publicly available on registry
July 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJune 20, 2012
June 1, 2012
2.3 years
July 8, 2009
June 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure is HDL-C
12 weeks and 24 weeks
Secondary Outcomes (1)
Serum lipids, glucose, HbA1c, anthropometrics and blood pressure
12 weeks and 24 weeks
Interventions
Peanuts and peanut butter
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Allergy to peanuts
- Smokers
- History of irritable bowel disease or diverticulitis
- Statin therapy (unless stable statin dose for 3 months)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Loma Linda Universitylead
- National Peanut Boardcollaborator
Study Sites (1)
Loma Linda University Medical Center Diabetes Treatment Center
Loma Linda, California, 92350, United States
Related Publications (1)
Wien M, Oda K, Sabate J. A randomized controlled trial to evaluate the effect of incorporating peanuts into an American Diabetes Association meal plan on the nutrient profile of the total diet and cardiometabolic parameters of adults with type 2 diabetes. Nutr J. 2014 Jan 22;13:10. doi: 10.1186/1475-2891-13-10.
PMID: 24450471DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joan Sabaté, MD, DrPh
Chair, Department of Nutrition
- STUDY DIRECTOR
Michelle Wien, DrPH
Assistant Professor, Department of Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 8, 2009
First Posted
July 10, 2009
Study Start
June 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
June 20, 2012
Record last verified: 2012-06