Effect of Dietary Fat When Eaten With Fructose Versus Glucose (Fructose)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Body Weight Changes	Other: 40% Fat Diet, 20% Fructose Beverage; Other: 20% Glucose Beverage	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	19 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Prevention
Official Title:	Effect of Dietary Fat When Eaten With Fructose vs. Glucose on Insulin Resistance and Liver Fat
Study Start Date :	October 2009
Actual Primary Completion Date :	March 2015
Actual Study Completion Date :	March 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: High Fat Diet with Fructose; 40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein	Other: 40% Fat Diet, 20% Fructose Beverage; 40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein; Other Name: Fructose vs. Glucose
Experimental: High Fat Diet with Glucose; 40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein	Other: 20% Glucose Beverage; 40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein; Other Name: Fructose vs. Glucose
Experimental: Low Fat Diet with Glucose; 20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein.	Other: 20% Glucose Beverage; 20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein; Other Name: Fructose vs Glucose

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	28 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Louisiana
Pennintgon Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

Pennington Biomedical Research Center

USDA Beltsville Human Nutrition Research Center

Investigators

Principal Investigator:	George A Bray, MD	Pennington Biomedical Research Center
Study Chair:	Sudip Bajpcyi, PhD	Pennington Biomedical Research Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	George A. Bray, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:	NCT01061346 History of Changes
Other Study ID Numbers:	PBRC 29025
First Posted:	February 3, 2010
Last Update Posted:	January 25, 2016
Last Verified:	January 2016

Keywords provided by George A. Bray, Pennington Biomedical Research Center:

Fructose; Glucose

Additional relevant MeSH terms:

Body Weight; Body Weight Changes; Signs and Symptoms