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

This study has been completed.
Sponsor:
Collaborator:
Peanut Institute
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University
ClinicalTrials.gov Identifier:
NCT01405300
First received: July 27, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Cardiovascular Disease
Dietary Supplement: Control
Dietary Supplement: Peanut
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effects of Peanuts and Peanut Products on Glucose Control and Vascular Function

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Change from baseline in Flow-Mediated Dilation at 4 hours postprandial [ Time Frame: 0 min; 240 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in oxidative stress over 4 hours postprandial [ Time Frame: 0 min, 30 min, 60 min, 120 min, 240 min ] [ Designated as safety issue: No ]
  • Change from baseline in serum lipids over 4 hours postprandial [ Time Frame: 0 min, 30 min, 60 min, 120 min, 240 min ] [ Designated as safety issue: No ]
  • Change from baseline in serum glucose over 4 hours postprandial [ Time Frame: 0 min, 30 min, 60 min, 120 min, 240 min ] [ Designated as safety issue: No ]
  • Change from baseline in serum insulin over 4 hours postprandial [ Time Frame: 0 min, 30 min, 60 min, 120 min, 240 min ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2011
Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01405300

Locations
United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
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
  More Information

No publications provided

Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT01405300     History of Changes
Other Study ID Numbers: PKE PPNUT
Study First Received: July 27, 2011
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014