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

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

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.

Study Overview

• Status: Completed
• Conditions: Body Weight Changes
• Intervention / Treatment: Other: 40% Fat Diet, 20% Fructose Beverage; Other: 20% Glucose Beverage; Other: 20% Glucose Beverage

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: Fructose vs. Glucose; Other: 20% Glucose Beverage; 20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein; Other Names: Fructose vs Glucose
Experimental: Low Fat Diet with Glucose; 20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein.	Other: 20% Glucose Beverage; 40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein; Other Names: Fructose vs. Glucose; Other: 20% Glucose Beverage; 20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein; Other Names: Fructose vs Glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: February 1, 2010
• First Submitted That Met QC Criteria: February 2, 2010
• First Posted (Estimate): February 3, 2010

Study Record Updates

• Last Update Posted (Estimate): January 25, 2016
• Last Update Submitted That Met QC Criteria: January 22, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Fructose; Glucose
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: PBRC 29025