NCT01405300

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

2.8 years

First QC Date

July 27, 2011

Last Update Submit

August 16, 2023

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Flow-Mediated Dilation at 4 hours postprandial

    0 min; 240 min

Secondary Outcomes (4)

  • Change from baseline in oxidative stress over 4 hours postprandial

    0 min, 30 min, 60 min, 120 min, 240 min

  • Change from baseline in serum lipids over 4 hours postprandial

    0 min, 30 min, 60 min, 120 min, 240 min

  • Change from baseline in serum glucose over 4 hours postprandial

    0 min, 30 min, 60 min, 120 min, 240 min

  • Change from baseline in serum insulin over 4 hours postprandial

    0 min, 30 min, 60 min, 120 min, 240 min

Study Arms (2)

Peanut

EXPERIMENTAL
Dietary Supplement: Peanut

Control

PLACEBO COMPARATOR
Dietary Supplement: Control

Interventions

ControlDIETARY_SUPPLEMENT

34.8 g dextrose, 150 g heavy whipping cream, 39g chocolate syrup, 15 g sunflower oil, 22 g safflower oil, 27 g powdered egg whites, 9.6 g of fiber supplement, water and crushed ice. It will deliver \~1200 kcal.

Control
PeanutDIETARY_SUPPLEMENT

34.8 g dextrose. 137 g heavy whipping cream, 39g chocolate syrup + 3 oz peanuts with skin. It will deliver \~1200 kcal.

Peanut

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

  • 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.

    PMID: 28356431DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Penny M Kris-Etherton, PhD, RD

    Penn State University

    PRINCIPAL INVESTIGATOR

  • Ann C Skulas-Ray, PhD

    Penn State University

    STUDY DIRECTOR

  • Xiaoran Liu

    Penn State University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2011

First Posted

July 29, 2011

Study Start

August 1, 2011

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

August 21, 2023

Record last verified: 2023-08

Locations

US(1)