- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01173042
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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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