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OpenTrials
Completed

NCT Number: NCT01061346

Effect of Dietary Fat When Eaten With Fructose Versus Glucose

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.

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Key information

Age range

28 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennintgon Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

40% Fat Diet, 20% Fructose Beverage

Other

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

Other names: Fructose vs. Glucose

20% Glucose Beverage

Other

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

Other names: Fructose vs. Glucose

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.

    Time frame: One Month

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • USDA Beltsville Human Nutrition Research Center

Registry information

Official study title

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

Acronym: Fructose

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2010
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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