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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01173042
Other study ID # PKE105
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 2009
Est. completion date February 2010

Study information

Verified date August 2023
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date February 2010
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 30 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Penn State University University Park Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Penn State University The Peanut Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum C-reactive protein 0min
Primary Serum C-reactive protein 60 min
Primary Serum C-reactive protein 120 min
Primary Serum C-reactive protein 240 min
Secondary Serum Glucose 0 min
Secondary Serum Insulin 0 min
Secondary Serum Triglycerides 0 min
Secondary Serum Glucose 60 min
Secondary Serum Glucose 120 min
Secondary Serum Glucose 240 min
Secondary Serum Insulin 60 min
Secondary Serum Insulin 120 min
Secondary Serum Insulin 240 min
Secondary Serum Triglycerides 60 min
Secondary Serum Triglycerides 120 min
Secondary Serum Triglycerides 240 min
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