Effect of Dietary Fat When Eaten With Fructose Versus Glucose

NCT ID: NCT01061346

Last Updated: 2016-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2015-03-31

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.

Conditions

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Body Weight Changes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High Fat Diet with Fructose

40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein

Group Type EXPERIMENTAL

40% Fat Diet, 20% Fructose Beverage

Intervention Type OTHER

40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein

High Fat Diet with Glucose

40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein

Group Type EXPERIMENTAL

20% Glucose Beverage

Intervention Type OTHER

40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein

Low Fat Diet with Glucose

20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein.

Group Type EXPERIMENTAL

20% Glucose Beverage

Intervention Type OTHER

20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein

Interventions

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40% Fat Diet, 20% Fructose Beverage

40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein

Intervention Type OTHER

20% Glucose Beverage

40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein

Intervention Type OTHER

20% Glucose Beverage

20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein

Intervention Type OTHER

Other Intervention Names

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Fructose vs. Glucose Fructose vs. Glucose Fructose vs Glucose

Eligibility Criteria

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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
Minimum Eligible Age

28 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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George A. Bray

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George A Bray, MD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Sudip Bajpcyi, PhD

Role: STUDY_CHAIR

Pennington Biomedical Research Center

Locations

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Pennintgon Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PBRC 29025

Identifier Type: -

Identifier Source: org_study_id

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