The Effects of Peanuts and Peanut Products on Glucose Control and Vascular Function

August 16, 2023 updated by: Penn State University
Pilot study data have demonstrated that peanuts ameliorate the postprandial glucose and insulin response when incorporated into an acute high fat/high glucose meal. However, it is unclear whether acute consumption of peanuts can also influence vascular function. This study will therefore evaluate the effects of acute peanut consumption on vascular function, glycemic control, and plasma lipids. The hypothesis is that that addition of peanuts to a high fat/high glucose meal will reduce the production of triglycerides, glucose, and improve endothelial function as measured by flow-mediated dilation (FMD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Penn State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 20-50 years of age
  • LDL-C below 160 mg/dL
  • Triglyceride below 350 mg/dL
  • Blood pressure within normal ranges (below 140/90 mmHg)
  • Not taking medication for elevated lipids, blood pressure or glucose

Exclusion Criteria:

  • Allergies to peanuts or dairy products
  • Known intolerance for high fat meals
  • History of cardiovascular disease (CVD), kidney disease, diabetes or inflammatory diseases such as GI disorders and arthritis
  • Use of non-steroidal anti-inflammatories or immunosuppressants
  • Conditions requiring the use of steroids
  • Use of medication or supplements for elevated lipids, blood pressure or glucose
  • Donation of blood or plasma during the study
  • History of thyroid disease
  • Women
  • Lactose intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Dietary supplement: Control
34.8 g dextrose, 150 g heavy whipping cream, 39g chocolate syrup, 15 g sunflower oil, 22 g safflower oil, 27 g powdered egg whites, 9.6 g of fiber supplement, water and crushed ice. It will deliver ~1200 kcal.
Experimental: Peanut
Dietary supplement: Peanut
34.8 g dextrose. 137 g heavy whipping cream, 39g chocolate syrup + 3 oz peanuts with skin. It will deliver ~1200 kcal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Flow-Mediated Dilation at 4 hours postprandial
Time Frame: 0 min; 240 min
0 min; 240 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in oxidative stress over 4 hours postprandial
Time Frame: 0 min, 30 min, 60 min, 120 min, 240 min
0 min, 30 min, 60 min, 120 min, 240 min
Change from baseline in serum lipids over 4 hours postprandial
Time Frame: 0 min, 30 min, 60 min, 120 min, 240 min
0 min, 30 min, 60 min, 120 min, 240 min
Change from baseline in serum glucose over 4 hours postprandial
Time Frame: 0 min, 30 min, 60 min, 120 min, 240 min
0 min, 30 min, 60 min, 120 min, 240 min
Change from baseline in serum insulin over 4 hours postprandial
Time Frame: 0 min, 30 min, 60 min, 120 min, 240 min
0 min, 30 min, 60 min, 120 min, 240 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

Peanut Institute

Investigators

  • Principal Investigator: Penny M Kris-Etherton, PhD, RD, Penn State University
  • Study Director: Ann C Skulas-Ray, PhD, Penn State University
  • Study Director: Xiaoran Liu, Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 27, 2011

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimated)

July 29, 2011

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKE PPNUT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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