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Clinical Trials/NCT01405300
NCT01405300
Completed
Phase 1

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

Penn State University1 site in 1 country20 target enrollmentStarted: August 2011Last updated:
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ConditionsCardiovascular Disease

Overview

Phase
Phase 1
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Change from baseline in Flow-Mediated Dilation at 4 hours postprandial
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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
  • •Lactose intolerance

Outcomes

Primary Outcomes

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

Time Frame: 0 min; 240 min

Secondary Outcomes

  • Change from baseline in serum glucose over 4 hours postprandial(0 min, 30 min, 60 min, 120 min, 240 min)
  • Change from baseline in serum insulin over 4 hours postprandial(0 min, 30 min, 60 min, 120 min, 240 min)
  • Change from baseline in oxidative stress over 4 hours postprandial(0 min, 30 min, 60 min, 120 min, 240 min)
  • Change from baseline in serum lipids over 4 hours postprandial(0 min, 30 min, 60 min, 120 min, 240 min)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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