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

August 16, 2023 updated by: Penn State University

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Penn State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Shake containing heavy whipping cream, glucose and chocolate syrup
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
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum C-reactive protein
Time Frame: 0min
0min
Serum C-reactive protein
Time Frame: 60 min
60 min
Serum C-reactive protein
Time Frame: 120 min
120 min
Serum C-reactive protein
Time Frame: 240 min
240 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Glucose
Time Frame: 0 min
0 min
Serum Insulin
Time Frame: 0 min
0 min
Serum Triglycerides
Time Frame: 0 min
0 min
Serum Glucose
Time Frame: 60 min
60 min
Serum Glucose
Time Frame: 120 min
120 min
Serum Glucose
Time Frame: 240 min
240 min
Serum Insulin
Time Frame: 60 min
60 min
Serum Insulin
Time Frame: 120 min
120 min
Serum Insulin
Time Frame: 240 min
240 min
Serum Triglycerides
Time Frame: 60 min
60 min
Serum Triglycerides
Time Frame: 120 min
120 min
Serum Triglycerides
Time Frame: 240 min
240 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

July 29, 2010

First Posted (Estimated)

July 30, 2010

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKE105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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