Effects of Peanut Consumption on Postprandial Inflammation, Glucose and Triglycerides

NCT ID: NCT01173042

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Shake containing heavy whipping cream, glucose and chocolate syrup

Group Type PLACEBO_COMPARATOR

Glucose and whipping cream

Intervention Type DIETARY_SUPPLEMENT

An oral liquid glucose (75g) and fat (high saturated fat from 60g heavy whipping cream) load. Chocolate syrup is added for flavor.

Peanut

Shake containing control (whipping cream, glucose and chocolate syrup) + 3oz of peanuts

Group Type EXPERIMENTAL

Peanuts

Intervention Type DIETARY_SUPPLEMENT

Shake containing 3.0oz of peanuts (including skin) + control (heavy whipping cream, glucose and chocolate syrup)

Oil blend

Shake containing control (heavy whipping cream, glucose and chocolate syrup) + oil blend (equivalent to fatty acids provided in 3oz peanuts)

Group Type EXPERIMENTAL

Oil Blend

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Peanuts

Shake containing 3.0oz of peanuts (including skin) + control (heavy whipping cream, glucose and chocolate syrup)

Intervention Type 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.

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Peanut Institute

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alison M Hill, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Penn State University, Department of Nutritiontal Sciences

Penny M. Kris-Etherton, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Penn State University, Department of Nutritional Sciences

Li Wang

Role: STUDY_DIRECTOR

Penn State University, Department of Nutritional Sciences

Locations

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Penn State University

University Park, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PKE105

Identifier Type: -

Identifier Source: org_study_id

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