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Clinical Trials/NCT01061346
NCT01061346CompletedNot Applicable

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

Pennington Biomedical Research Center2 sites in 1 country19 target enrollmentStarted: October 2009Last updated:
Conditions

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

George A. Bray

Principal Investigator

Pennington Biomedical Research Center

Study Sites (2)

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