Effect of Dietary Fat When Eaten With Fructose vs. Glucose on Insulin Resistance and Liver Fat
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 28 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •BMI between 25 and 35 kg/m2 inclusive
- •At least one of the following:
- •Impaired fasting glucose between 100-125 mg/dl inclusive
- •HDL below 40 mg/dl for men or below 50 mg/dl for females
- •Triglycerides between 150 mg/dl and 400 mg/dl inclusive
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
George A. Bray
Principal Investigator
Pennington Biomedical Research Center