Effect of Dietary Fat When Eaten With Fructose Versus Glucose

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Dietary Fat When Eaten With Fructose vs. Glucose on Insulin Resistance and Liver Fat

Conditions
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Body Weight Changes

Intervention / Treatment
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* Other: 40% Fat Diet, 20% Fructose Beverage
* Other: 20% Glucose Beverage
* Other: 20% Glucose Beverage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Fat Diet with Fructose<br>40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein | Other: 40% Fat Diet, 20% Fructose Beverage<br>* 40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein<br>* Other names: Fructose vs. Glucose;|
| Experimental: High Fat Diet with Glucose<br>40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein | Other: 20% Glucose Beverage<br>* 40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein<br>* Other names: Fructose vs. Glucose;|
| Experimental: Low Fat Diet with Glucose<br>20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein. | Other: 20% Glucose Beverage<br>* 20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein<br>* Other names: Fructose vs Glucose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fructose, Glucose