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Effects of Peanut Consumption on Postprandial Inflammation, Glucose and Triglycerides (PKEPEANUT)

This study has been completed.
Sponsor:
Collaborator:
The Peanut Institute
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT01173042
First received: April 13, 2010
Last updated: July 29, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
 Dietary Supplement: Peanuts
Dietary Supplement: Glucose and whipping cream
Dietary Supplement: Oil Blend
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pilot Study of the Effect of Peanut Consumption on Postprandial Inflammatory Status, Glucose and Triglycerides

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Serum C-reactive protein [ Time Frame: 0min ] [ Designated as safety issue: No ]
  • Serum C-reactive protein [ Time Frame: 60 min ] [ Designated as safety issue: No ]
  • Serum C-reactive protein [ Time Frame: 120 min ] [ Designated as safety issue: No ]
  • Serum C-reactive protein [ Time Frame: 240 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum Glucose [ Time Frame: 0 min ] [ Designated as safety issue: No ]
  • Serum Insulin [ Time Frame: 0 min ] [ Designated as safety issue: No ]
  • Serum Triglycerides [ Time Frame: 0 min ] [ Designated as safety issue: No ]
  • Serum Glucose [ Time Frame: 60 min ] [ Designated as safety issue: No ]
  • Serum Glucose [ Time Frame: 120 min ] [ Designated as safety issue: No ]
  • Serum Glucose [ Time Frame: 240 min ] [ Designated as safety issue: No ]
  • Serum Insulin [ Time Frame: 60 min ] [ Designated as safety issue: No ]
  • Serum Insulin [ Time Frame: 120 min ] [ Designated as safety issue: No ]
  • Serum Insulin [ Time Frame: 240 min ] [ Designated as safety issue: No ]
  • Serum Triglycerides [ Time Frame: 60 min ] [ Designated as safety issue: No ]
  • Serum Triglycerides [ Time Frame: 120 min ] [ Designated as safety issue: No ]
  • Serum Triglycerides [ Time Frame: 240 min ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: August 2009
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Shake containing heavy whipping cream, glucose and chocolate syrup
 Dietary Supplement: Glucose and whipping cream
An oral liquid glucose (75g) and fat (high saturated fat from 60g heavy whipping cream) load. Chocolate syrup is added for flavor.
Experimental: Peanut
Shake containing control (whipping cream, glucose and chocolate syrup) + 3oz of peanuts
 Dietary Supplement: Peanuts
Shake containing 3.0oz of peanuts (including skin) + control (heavy whipping cream, glucose and chocolate syrup)
Other Name: Peanuts
Experimental: Oil blend
Shake containing control (heavy whipping cream, glucose and chocolate syrup) + oil blend (equivalent to fatty acids provided in 3oz peanuts)
 Dietary Supplement: Oil Blend
Shake containing an oil blend (sunflower, sesame, olive and palm oils) + control (heavy whipping cream, glucose and chocolate syrup). The amount of oil added to the control will provide an equivalent amount of fat to that provided in 3 oz (85g) of peanuts

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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI >28
  • LDL_C below 130 mg/dl
  • TG below 350 mg/dl
  • Blood pressure within normal ranges (below 140/90 mmHg)

Exclusion Criteria:

  • Smoking
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173042

Locations
United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
The Peanut Institute
Investigators
Principal Investigator: Alison M Hill, Ph.D Penn State University, Department of Nutritiontal Sciences
Principal Investigator: Penny M. Kris-Etherton, Ph.D Penn State University, Department of Nutritional Sciences
Study Director: Li Wang Penn State University, Department of Nutritional Sciences
  More Information

No publications provided

Responsible Party: Penny Kris-Etherton, Penn State University
ClinicalTrials.gov Identifier: NCT01173042     History of Changes
Other Study ID Numbers: PKE105
Study First Received: April 13, 2010
Last Updated: July 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Overweight
Obese

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013