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

NCT ID: NCT01405300

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-06-30

Brief Summary

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).

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Peanut

Group Type: EXPERIMENTAL

Peanut

Intervention Type: DIETARY_SUPPLEMENT

34.8 g dextrose. 137 g heavy whipping cream, 39g chocolate syrup + 3 oz peanuts with skin. It will deliver \~1200 kcal.

Control

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Peanut Institute

UNKNOWN

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Penny M Kris-Etherton, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Ann C Skulas-Ray, PhD

Role: STUDY_DIRECTOR

Penn State University

Xiaoran Liu

Role: STUDY_DIRECTOR

Penn State University

Locations

Penn State University

University Park, Pennsylvania, United States

Countries

United States

References

Liu X, Hill AM, West SG, Gabauer RM, McCrea CE, Fleming JA, Kris-Etherton PM. Acute Peanut Consumption Alters Postprandial Lipids and Vascular Responses in Healthy Overweight or Obese Men. J Nutr. 2017 May;147(5):835-840. doi: 10.3945/jn.116.246785. Epub 2017 Mar 29.

Reference Type: DERIVED

PMID: 28356431 (View on PubMed)

Other Identifiers

PKE PPNUT

Identifier Type: -

Identifier Source: org_study_id