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Clinical Trials/NCT01173042
NCT01173042
Completed
Phase 1

Pilot Study of the Effect of Peanut Consumption on Postprandial Inflammatory Status, Glucose and Triglycerides

Penn State University1 site in 1 country6 target enrollmentStarted: August 2009Last updated:

Overview

Phase
Phase 1
Status
Completed
Enrollment
6
Locations
1
Primary Endpoint
Serum C-reactive protein

Overview

Brief Summary

This pilot study will investigate the effects of acute peanut consumption on markers of inflammation, triglycerides and glucose. The hypothesis is that a high glucose/SFA meal will increase postprandial production of the inflammatory marker, C-reactive protein (CRP), and that the addition of peanuts to the control meal will reduce the production of CRP, as well as triglycerides and glucose.

Detailed Description

Previous research has demonstrated that a single meal high in saturated fatty acids (SFA) and glucose can induce increases in IL-6, TNF-α and CRP in abdominally obese and diabetic subjects. As over two-thirds of the U.S. population is overweight or obese, it is important to identify foods that can attenuate postprandial increases in lipids, glucose and inflammation in this population. Therefore, the purpose of the pilot study is to determine whether a high SFA / high glucose control meal will induce an acute inflammatory response in overweight individuals, and whether the addition of peanuts to this meal will ameliorate this response. To ensure that these effects are due to peanuts, and not to the increase in total fat, we will compare this response to another test meal that includes an oil blend with a similar fatty acid composition to peanuts.

Study Design

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

Eligibility Criteria

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

Inclusion Criteria

  • LDL_C below 130 mg/dl
  • TG below 350 mg/dl
  • Blood pressure within normal ranges (below 140/90 mmHg)

Exclusion Criteria

  • Allergies to peanuts or dairy products
  • Known intolerance for high fat meals
  • History of CVD, kidney disease, diabetes or inflammatory disease
  • 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

Outcomes

Primary Outcomes

Serum C-reactive protein

Time Frame: 240 min

Secondary Outcomes

  • Serum Triglycerides(240 min)
  • Serum Glucose(240 min)
  • Serum Insulin(240 min)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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