Effect of Dietary Fat When Eaten With Fructose Versus Glucose

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
George A. Bray, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01061346
First received: February 1, 2010
Last updated: December 13, 2012
Last verified: December 2012

February 1, 2010
December 13, 2012
October 2009
August 2013   (final data collection date for primary outcome measure)
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. [ Time Frame: One Month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01061346 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Dietary Fat When Eaten With Fructose Versus Glucose
Effect of Dietary Fat When Eaten With Fructose vs. Glucose on Insulin Resistance and Liver Fat

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Body Weight Changes
  • Other: 40% Fat Diet, 20% Fructose Beverage
    40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein
    Other Name: Fructose vs. Glucose
  • Other: 20% Glucose Beverage
    40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein
    Other Name: Fructose vs. Glucose
  • Other: 20% Glucose Beverage
    20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein
    Other Name: Fructose vs Glucose
  • Experimental: High Fat Diet with Fructose
    40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein
    Intervention: Other: 40% Fat Diet, 20% Fructose Beverage
  • Experimental: High Fat Diet with Glucose
    40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein
    Intervention: Other: 20% Glucose Beverage
  • Experimental: Low Fat Diet with Glucose
    20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein.
    Intervention: Other: 20% Glucose Beverage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
28 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01061346
PBRC29025 Fructose
No
George A. Bray, Pennington Biomedical Research Center
Pennington Biomedical Research Center
USDA Beltsville Human Nutrition Research Center
Principal Investigator: George A Bray, MD Pennington Biomedical Research Center
Study Chair: Sudip Bajpcyi, PhD Pennington Biomedical Research Center
Pennington Biomedical Research Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP