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Effect of Dietary Fat When Eaten With Fructose Versus Glucose (Fructose)
This study has been completed.
Sponsor:
Pennington Biomedical Research Center
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
George A. Bray, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01061346
First received: February 1, 2010
Last updated: January 22, 2016
Last verified: January 2016
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Purpose
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 | Intervention |
|---|---|
| Body Weight Changes | Other: 40% Fat Diet, 20% Fructose Beverage Other: 20% Glucose Beverage |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Prevention |
| Official Title: | Effect of Dietary Fat When Eaten With Fructose vs. Glucose on Insulin Resistance and Liver Fat |
Resource links provided by NLM:
Further study details as provided by George A. Bray, Pennington Biomedical Research Center:
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. [ Time Frame: One Month ]
| Enrollment: | 19 |
| Study Start Date: | October 2009 |
| Study Completion Date: | March 2015 |
| Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| 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:
- 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01061346
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061346
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
| Responsible Party: | George A. Bray, Principal Investigator, Pennington Biomedical Research Center |
| ClinicalTrials.gov Identifier: | NCT01061346 History of Changes |
| Other Study ID Numbers: |
PBRC 29025 |
| Study First Received: | February 1, 2010 |
| Last Updated: | January 22, 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 |
ClinicalTrials.gov processed this record on June 23, 2017