Effect of Dietary Fat When Eaten With Fructose Versus Glucose

Body Weight Changes Clinical Trial

— Fructose  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061346
• Other study ID #: PBRC 29025
• Status: Completed
• Phase: N/A
• First received: February 1, 2010
• Last updated: January 22, 2016
• Start date: October 2009
• Est. completion date: March 2015

Study information

• Verified date: January 2016
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 28 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes

Intervention

Other:
• 40% Fat Diet, 20% Fructose Beverage
40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein
• 20% Glucose Beverage
40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein
• 20% Glucose Beverage
20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein

Locations

Country	Name	City	State
United States	Pennintgon Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No