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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405300
• Other study ID #: PKE PPNUT
• Status: Completed
• Phase: Phase 1
• Start date: August 2011
• Est. completion date: June 2014

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Peanut Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Flow-Mediated Dilation at 4 hours postprandial		0 min; 240 min
Secondary	Change from baseline in oxidative stress over 4 hours postprandial		0 min, 30 min, 60 min, 120 min, 240 min
Secondary	Change from baseline in serum lipids over 4 hours postprandial		0 min, 30 min, 60 min, 120 min, 240 min
Secondary	Change from baseline in serum glucose over 4 hours postprandial		0 min, 30 min, 60 min, 120 min, 240 min
Secondary	Change from baseline in serum insulin over 4 hours postprandial		0 min, 30 min, 60 min, 120 min, 240 min