Clinical trial NCT01173042: Effects of Peanut Consumption on Postprandial Inflammation, Glucose and Triglycerides
Official title: Pilot Study of the Effect of Peanut Consumption on Postprandial Inflammatory Status, Glucose and Triglycerides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Disease
Keywords: Overweight
Obese
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: The Peanut Institute
First posted: 2010-07-30
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum C-reactive protein
timeFrame: 0min
measure: Serum C-reactive protein
timeFrame: 60 min
measure: Serum C-reactive protein
timeFrame: 120 min
measure: Serum C-reactive protein
timeFrame: 240 min
Secondary outcomes:
measure: Serum Glucose
timeFrame: 0 min
measure: Serum Insulin
timeFrame: 0 min
measure: Serum Triglycerides
timeFrame: 0 min
measure: Serum Glucose
timeFrame: 60 min
measure: Serum Glucose
timeFrame: 120 min
measure: Serum Glucose
timeFrame: 240 min
measure: Serum Insulin
timeFrame: 60 min
measure: Serum Insulin
timeFrame: 120 min
measure: Serum Insulin
timeFrame: 240 min
measure: Serum Triglycerides
timeFrame: 60 min
measure: Serum Triglycerides
timeFrame: 120 min
measure: Serum Triglycerides
timeFrame: 240 min
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University, Department of Nutritiontal Sciences
name: Alison M Hill, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University, Department of Nutritional Sciences
name: Penny M. Kris-Etherton, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University, Department of Nutritional Sciences
name: Li Wang
role: STUDY_DIRECTOR
References: