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

Primary Purpose

Body Weight Changes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
40% Fat Diet, 20% Fructose Beverage
20% Glucose Beverage
20% Glucose Beverage
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Weight Changes focused on measuring Fructose, Glucose

Eligibility Criteria

28 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pennintgon Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

High Fat Diet with Fructose

High Fat Diet with Glucose

Low Fat Diet with Glucose

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2010
Last Updated
January 22, 2016
Sponsor
Pennington Biomedical Research Center
Collaborators
USDA Beltsville Human Nutrition Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01061346
Brief Title
Effect of Dietary Fat When Eaten With Fructose Versus Glucose
Acronym
Fructose
Official Title
Effect of Dietary Fat When Eaten With Fructose vs. Glucose on Insulin Resistance and Liver Fat
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
USDA Beltsville Human Nutrition Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes
Keywords
Fructose, Glucose

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Fat Diet with Fructose
Arm Type
Experimental
Arm Description
40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein
Arm Title
High Fat Diet with Glucose
Arm Type
Experimental
Arm Description
40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein
Arm Title
Low Fat Diet with Glucose
Arm Type
Experimental
Arm Description
20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein.
Intervention Type
Other
Intervention Name(s)
40% Fat Diet, 20% Fructose Beverage
Other Intervention Name(s)
Fructose vs. Glucose
Intervention Description
40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein
Intervention Type
Other
Intervention Name(s)
20% Glucose Beverage
Other Intervention Name(s)
Fructose vs. Glucose
Intervention Description
40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein
Intervention Type
Other
Intervention Name(s)
20% Glucose Beverage
Other Intervention Name(s)
Fructose vs Glucose
Intervention Description
20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George A Bray, MD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sudip Bajpcyi, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Chair
Facility Information:
Facility Name
Pennintgon Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

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Effect of Dietary Fat When Eaten With Fructose Versus Glucose

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