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Effect of Dietary Fat When Eaten With Fructose Versus Glucose (Fructose)

This study has been completed.
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: January 22, 2016
Last verified: January 2016
History of Changes
  Purpose
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 Intervention
Body Weight Changes
 Other: 40% Fat Diet, 20% Fructose Beverage
Other: 20% Glucose Beverage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Dietary Fat When Eaten With Fructose vs. Glucose on Insulin Resistance and Liver Fat

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • 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 ]
Enrollment: 19
Study Start Date: October 2009
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Fructose vs Glucose

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.

  Eligibility
Ages Eligible for Study:   28 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061346

Locations
United States, Louisiana
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
  More Information

Responsible Party: George A. Bray, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01061346     History of Changes
Other Study ID Numbers: PBRC 29025 
Study First Received: February 1, 2010
Last Updated: January 22, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Fructose
Glucose

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 23, 2016