Effect of Dietary Fat When Eaten With Fructose Versus Glucose

Not Applicable

Completed

• Conditions: Body Weight Changes
• Interventions: Other: 40% Fat Diet, 20% Fructose Beverage; Other: 20% Glucose Beverage

• Registration Number: NCT01061346
• Lead Sponsor: Pennington Biomedical Research Center

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Fat Diet with Fructose	40% Fat Diet, 20% Fructose Beverage	40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein
High Fat Diet with Glucose	20% Glucose Beverage	40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein
Low Fat Diet with Glucose	20% Glucose Beverage	20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pennintgon Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States