Effect of Dietary Fat When Eaten With Fructose Versus Glucose

NCT01061346 | Completed

• 1 other identifier: PBRC 29025
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Weight Changes

Keywords

Fructose; Glucose

Outcome Measures

Primary Outcomes (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.

  One Month

Study Arms (3)

High Fat Diet with Fructose

EXPERIMENTAL

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

Other: 40% Fat Diet, 20% Fructose Beverage

High Fat Diet with Glucose

EXPERIMENTAL

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

Other: 20% Glucose Beverage

Low Fat Diet with Glucose

EXPERIMENTAL

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

Other: 20% Glucose Beverage

Interventions

40% Fat Diet, 20% Fructose Beverage OTHER

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

Also known as: Fructose vs. Glucose

High Fat Diet with Fructose

20% Glucose Beverage OTHER

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

Also known as: Fructose vs. Glucose

High Fat Diet with Glucose

Eligibility Criteria

• Age: 28 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• USDA Beltsville Human Nutrition Research Center: collaborator

Study Sites (1)

Pennintgon Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• George A Bray, MD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• Sudip Bajpcyi, PhD

  Pennington Biomedical Research Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 3, 2010
• Study Start: October 1, 2009
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 25, 2016

Record last verified: 2016-01

Locations

US (1)