Clinical trial NCT01405300: The Effects of Peanuts and Peanut Products on Glucose Control and Vascular Function
Official title: The Effects of Peanuts and Peanut Products on Glucose Control and Vascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Disease
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Peanut Institute
First posted: 2011-07-29
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pilot study data have demonstrated that peanuts ameliorate the postprandial glucose and insulin response when incorporated into an acute high fat/high glucose meal. However, it is unclear whether acute consumption of peanuts can also influence vascular function. This study will therefore evaluate the effects of acute peanut consumption on vascular function, glycemic control, and plasma lipids. The hypothesis is that that addition of peanuts to a high fat/high glucose meal will reduce the production of triglycerides, glucose, and improve endothelial function as measured by flow-mediated dilation (FMD).


Eligibility criteria: Inclusion Criteria:

* 20-50 years of age
* LDL-C below 160 mg/dL
* Triglyceride below 350 mg/dL
* Blood pressure within normal ranges (below 140/90 mmHg)
* Not taking medication for elevated lipids, blood pressure or glucose

Exclusion Criteria:

* Allergies to peanuts or dairy products
* Known intolerance for high fat meals
* History of cardiovascular disease (CVD), kidney disease, diabetes or inflammatory diseases such as GI disorders and arthritis
* 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
* Donation of blood or plasma during the study
* History of thyroid disease
* Women
* Lactose intolerance

Primary outcomes:
measure: Change from baseline in Flow-Mediated Dilation at 4 hours postprandial
timeFrame: 0 min; 240 min
Secondary outcomes:
measure: Change from baseline in oxidative stress over 4 hours postprandial
timeFrame: 0 min, 30 min, 60 min, 120 min, 240 min
measure: Change from baseline in serum lipids over 4 hours postprandial
timeFrame: 0 min, 30 min, 60 min, 120 min, 240 min
measure: Change from baseline in serum glucose over 4 hours postprandial
timeFrame: 0 min, 30 min, 60 min, 120 min, 240 min
measure: Change from baseline in serum insulin over 4 hours postprandial
timeFrame: 0 min, 30 min, 60 min, 120 min, 240 min
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny M Kris-Etherton, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Ann C Skulas-Ray, PhD
role: STUDY_DIRECTOR
affiliation: Penn State University
name: Xiaoran Liu
role: STUDY_DIRECTOR
References:
citation: Liu X, Hill AM, West SG, Gabauer RM, McCrea CE, Fleming JA, Kris-Etherton PM. Acute Peanut Consumption Alters Postprandial Lipids and Vascular Responses in Healthy Overweight or Obese Men. J Nutr. 2017 May;147(5):835-840. doi: 10.3945/jn.116.246785. Epub 2017 Mar 29.