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Dietary Treatment Study of Fat Synthesis and Risk of Cardiovascular Disease

Not Applicable
Conditions
Overweight and Obesity
Interventions
Other: High sugar/meal feed
Other: High sugar/ 3 meals a day
Other: High fat/meal feed
Other: High sugar/nibble
Other: High fat/nibble
Other: High fat/ 3 meals a day
Registration Number
NCT02075710
Lead Sponsor
University of California, San Francisco
Brief Summary

The purpose of this study is to find out how the amount of fat or sugar in a person's diet, or the number of meals eaten each day, affect the amount of fat that people's bodies make, the types of fats in the bloodstream, and how much fat is stored in the liver. The study is funded by the National Institutes of Health.

Detailed Description

The study consists of two 10-day feeding periods that are separated by approximately two weeks. During each feeding period all food and beverages to be consumed will be provided by the study.

In Study 1, participants will be randomly assigned to receive one of two diets. Both diets are designed to maintain weight at a constant level. The diets are balanced nutritionally and have the same amount of protein. One diet has higher amounts of sugar, while the other has higher amounts of fat. For one 10-day period, the diet will be fed as two large meals ('meal-feeding'). For the other 10-day period, the identical diet will be fed as 8 small meals ('nibbling'). Half of the participants will meal-feed first, while the other half will 'nibble' first. The order of nibbling or meal feeding will be determined randomly.

In Study 2, the number of meals eaten per day will remain fixed at three (no nibbling or meal feeding). Participants will receive both the diet higher in sugar and the diet higher in fat. However, they will be randomly assigned to start one followed by the other for each 10-day feeding period.

At the end of each 10-day feeding period, participants will spend two nights in a research ward (Clinical Research Center) to undergo testing.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
48
Inclusion Criteria
  • overweight or obese men and women
  • ages 20-65 years
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Exclusion Criteria
  • pregnancy or lactation within the past six months
  • type 1 or 2 diabetes mellitus]
  • AST and ALT above upper limit of normal (ULN)
  • fasting triglyceride or total cholesterol levels >ULN
  • Hgb below the lower of limit of normal
  • positive HIV antibody test or hepatitis serologies
  • use of any antidiabetic medications or lipid-lowering drugs
  • history of surgery for obesity
  • change in body weight >5% within preceding 6 months (self report)
  • claustrophobia, presence of metal implants
  • weight over 350 lbs
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
High sugar/nibbleHigh sugar/meal feedDiet high in simple sugar fed as 8 small meals daily
High sugar/nibbleHigh sugar/nibbleDiet high in simple sugar fed as 8 small meals daily
High fat/ 3 meals a dayHigh sugar/ 3 meals a dayDiet high in fat fed as 3 meals a day
High sugar/meal feedHigh sugar/nibbleDiet high in simple sugar fed as two large meals daily
High fat/meal feedHigh fat/nibbleDiet high in fat fed as two large meals daily
High fat/nibbleHigh fat/nibbleDiet high in fat fed as 8 small meals daily
High sugar/3 meals a dayHigh fat/ 3 meals a dayDiet high in simple sugar fed as 3 meals a day
High sugar/meal feedHigh sugar/meal feedDiet high in simple sugar fed as two large meals daily
High fat/ 3 meals a dayHigh fat/ 3 meals a dayDiet high in fat fed as 3 meals a day
High fat/meal feedHigh fat/meal feedDiet high in fat fed as two large meals daily
High sugar/3 meals a dayHigh sugar/ 3 meals a dayDiet high in simple sugar fed as 3 meals a day
Primary Outcome Measures
NameTimeMethod
Effect of meal composition on fractional de novo lipogenesis (fatty acid synthesis)After 10-day dietary period

Differences between high carbohydrate and high fat diets on postprandial de novo lipogenesis

De novo lipogenesis will be measured using stable (not radioactive) isotopes given intravenously and orally during feeding.

Secondary Outcome Measures
NameTimeMethod
Effect of meal frequency on fractional de novo lipogenesis (fatty acid synthesis)After 10-day dietary period

Differences between consuming the same diet as eight small meals per day or two larger meals per day on postprandial de novo lipogenesis.

Please see description of measurement of de novo lipogenesis under aim 1.

Trial Locations

Locations (1)

University of California, San Franciso, San Francisco General Hospital

🇺🇸

San Francisco, California, United States

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