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Completed

NCT Number: NCT01405300

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

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).

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

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.

Peanut

Dietary Supplement

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

Primary outcomes

  1. Change from baseline in Flow-Mediated Dilation at 4 hours postprandial

    Time frame: 0 min; 240 min

Secondary outcomes

  1. Change from baseline in oxidative stress over 4 hours postprandial

    Time frame: 0 min, 30 min, 60 min, 120 min, 240 min

  2. Change from baseline in serum lipids over 4 hours postprandial

    Time frame: 0 min, 30 min, 60 min, 120 min, 240 min

  3. Change from baseline in serum glucose over 4 hours postprandial

    Time frame: 0 min, 30 min, 60 min, 120 min, 240 min

  4. Change from baseline in serum insulin over 4 hours postprandial

    Time frame: 0 min, 30 min, 60 min, 120 min, 240 min

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Peanut Institute

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2011
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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