NCT01173042

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2009

Shorter than P25 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

Study Start

First participant enrolled

August 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 30, 2010

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

April 13, 2010

Last Update Submit

August 16, 2023

Conditions

Cardiovascular Disease

Keywords

OverweightObese

Outcome Measures

Primary Outcomes (4)

  • Serum C-reactive protein

    0min

  • Serum C-reactive protein

    60 min

  • Serum C-reactive protein

    120 min

  • Serum C-reactive protein

    240 min

Secondary Outcomes (12)

  • Serum Glucose

    0 min

  • Serum Insulin

    0 min

  • Serum Triglycerides

    0 min

  • Serum Glucose

    60 min

  • Serum Glucose

    120 min

  • +7 more secondary outcomes

Study Arms (3)

Control

PLACEBO COMPARATOR

Shake containing heavy whipping cream, glucose and chocolate syrup

Dietary Supplement: Glucose and whipping cream

Peanut

EXPERIMENTAL

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

Dietary Supplement: Peanuts

Oil blend

EXPERIMENTAL

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

Dietary Supplement: Oil Blend

Interventions

PeanutsDIETARY_SUPPLEMENT

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

Peanut
Glucose and whipping creamDIETARY_SUPPLEMENT

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

Control
Oil BlendDIETARY_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

Oil blend

Eligibility Criteria

Age30 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \>28
  • LDL\_C below 130 mg/dl
  • TG below 350 mg/dl
  • Blood pressure within normal ranges (below 140/90 mmHg)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesOverweightObesity

Interventions

Glucose

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Alison M Hill, Ph.D

    Penn State University, Department of Nutritiontal Sciences

    PRINCIPAL INVESTIGATOR

  • Penny M. Kris-Etherton, Ph.D

    Penn State University, Department of Nutritional Sciences

    PRINCIPAL INVESTIGATOR

  • Li Wang

    Penn State University, Department of Nutritional Sciences

    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

April 13, 2010

First Posted

July 30, 2010

Study Start

August 1, 2009

Primary Completion

January 1, 2010

Study Completion

February 1, 2010

Last Updated

August 21, 2023

Record last verified: 2023-08

Locations

US(1)