NCT00937222

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

2.3 years

First QC Date

July 8, 2009

Last Update Submit

June 19, 2012

Conditions

Keywords

diabetescholesterolpeanutspeanut butterdietary interventionHDL cholesterol

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 butterDIETARY_SUPPLEMENT

Peanuts and peanut butter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Loma Linda University Medical Center Diabetes Treatment Center

Loma Linda, California, 92350, United States

Location

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.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Joan Sabaté, MD, DrPh

    Chair, Department of Nutrition

    PRINCIPAL INVESTIGATOR
  • Michelle Wien, DrPH

    Assistant Professor, Department of Nutrition

    STUDY DIRECTOR

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

Locations