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

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ClinicalTrials.gov Identifier: NCT01173042
Recruitment Status : Completed
First Posted : July 30, 2010
Last Update Posted : May 31, 2017
Information provided by (Responsible Party):

Study Description
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.

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

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  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pilot Study of the Effect of Peanut Consumption on Postprandial Inflammatory Status, Glucose and Triglycerides
Study Start Date : August 2009
Primary Completion Date : January 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)
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

Outcome Measures

Primary Outcome Measures :
  1. Serum C-reactive protein [ Time Frame: 0min ]
  2. Serum C-reactive protein [ Time Frame: 60 min ]
  3. Serum C-reactive protein [ Time Frame: 120 min ]
  4. Serum C-reactive protein [ Time Frame: 240 min ]

Secondary Outcome Measures :
  1. Serum Glucose [ Time Frame: 0 min ]
  2. Serum Insulin [ Time Frame: 0 min ]
  3. Serum Triglycerides [ Time Frame: 0 min ]
  4. Serum Glucose [ Time Frame: 60 min ]
  5. Serum Glucose [ Time Frame: 120 min ]
  6. Serum Glucose [ Time Frame: 240 min ]
  7. Serum Insulin [ Time Frame: 60 min ]
  8. Serum Insulin [ Time Frame: 120 min ]
  9. Serum Insulin [ Time Frame: 240 min ]
  10. Serum Triglycerides [ Time Frame: 60 min ]
  11. Serum Triglycerides [ Time Frame: 120 min ]
  12. Serum Triglycerides [ Time Frame: 240 min ]

Eligibility Criteria

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173042

United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
The Peanut Institute
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

Additional Information:
Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT01173042     History of Changes
Other Study ID Numbers: PKE105
First Posted: July 30, 2010    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Penny Kris-Etherton, Penn State University:

Additional relevant MeSH terms:
Cardiovascular Diseases