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Effect of Dietary Fat When Eaten With Fructose Versus Glucose

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT01061346
Collaborator
USDA Beltsville Human Nutrition Research Center (U.S. Fed)
19
Enrollment
1
Location
3
Arms
65
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to test the effects on liver fat of varying fat intake in the presence of fructose or glucose. We hypothesize that higher dietary fat when eaten with fructose as compared to glucose will increase the amount of hepatic lipid as measured by magnetic resonance spectroscopy.

Condition or Disease Intervention/Treatment Phase
  • Other: 40% Fat Diet, 20% Fructose Beverage
  • Other: 20% Glucose Beverage
  • Other: 20% Glucose Beverage
 N/A

Detailed Description

After 2 screening visits including an exercise test, DEXA and CT scan, qualifiers begin a 7 day diet with 20% fat, 65% carbohydrate (with 20% glucose) and 15 % protein. Participants consume 2 meals per day at PBRC with lunch and weekend meals packed to go. Following a test day, participants are randomized to one of 3 diet assignments and then test again:

1)20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein 2)40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein 3)40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein On Day 7 and again 14 days later participants have labs, an oral Glucose tolerance test, hepatic and intramuscular lipid measures by MRS, vital signs and waist measurement.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Effect of Dietary Fat When Eaten With Fructose vs. Glucose on Insulin Resistance and Liver Fat
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: High Fat Diet with Fructose

40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein

Other: 40% Fat Diet, 20% Fructose Beverage
40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein
Other Names:
  • Fructose vs. Glucose

    		•
    Experimental: High Fat Diet with Glucose

    40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein

    Other: 20% Glucose Beverage
    40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein
    Other Names:
  • Fructose vs. Glucose

    		•
    Experimental: Low Fat Diet with Glucose

    20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein.

    Other: 20% Glucose Beverage
    20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein
    Other Names:
  • Fructose vs Glucose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evidence to determine whether intake in beverages that provide 20% fructose or a similar beverage made with glucose given with a higher fat diet has an effect on your body weight, blood pressure, fats in your liver or your blood sugar. [One Month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    28 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • BMI between 25 and 35 kg/m2 inclusive

    • At least one of the following:

    1. Impaired fasting glucose between 100-125 mg/dl inclusive

    2. HDL below 40 mg/dl for men or below 50 mg/dl for females

    3. Triglycerides between 150 mg/dl and 400 mg/dl inclusive

    4. Blood pressure above or equal to 135 / 85 mm Hg

    • Waist circumference >94cm (37 inches) for men or >80cm for women

    • Mainly Healthy

    Exclusion Criteria:

    • Unable or unlikely to eat study foods and only foods provided by PRBC

    • Taking routine medications except birth control pills

    • Smoke, Abuse drugs,or Alcohol

    • Pregnant or breastfeeding, irregular menstrual cycles, Post-menopausal,or PCOS

    • Diabetes, heart, lung, liver, blood, or Kidney disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pennintgon Biomedical Research Center Baton Rouge Louisiana United States 70808

    Sponsors and Collaborators

    • Pennington Biomedical Research Center
    • USDA Beltsville Human Nutrition Research Center

    Investigators

    • Principal Investigator: George A Bray, MD, Pennington Biomedical Research Center
    • Study Chair: Sudip Bajpcyi, PhD, Pennington Biomedical Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    George A. Bray, Principal Investigator, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT01061346
    Other Study ID Numbers:
    • PBRC 29025
    First Posted:
    Feb 3, 2010
    Last Update Posted:
    Jan 25, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by George A. Bray, Principal Investigator, Pennington Biomedical Research Center
    Fructose
    Glucose
    Additional relevant MeSH terms:
    Body Weight
    Body Weight Changes

    Study Results

    No Results Posted as of Jan 25, 2016