Dietary Treatment Study of Fat Synthesis and Risk of Cardiovascular Disease
Primary Purpose
Overweight and Obesity
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High sugar/meal feed
High sugar/nibble
High fat/meal feed
High fat/nibble
High sugar/ 3 meals a day
High fat/ 3 meals a day
Sponsored by

About this trial
This is an interventional other trial for Overweight and Obesity focused on measuring Diet, Sugar, Cardiovascular, Lipid
Eligibility Criteria
Inclusion Criteria:
- overweight or obese men and women
- ages 20-65 years
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
Sites / Locations
- University of California, San Franciso, San Francisco General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
High sugar/meal feed
High sugar/nibble
High fat/meal feed
High fat/nibble
High sugar/3 meals a day
High fat/ 3 meals a day
Arm Description
Diet high in simple sugar fed as two large meals daily
Diet high in simple sugar fed as 8 small meals daily
Diet high in fat fed as two large meals daily
Diet high in fat fed as 8 small meals daily
Diet high in simple sugar fed as 3 meals a day
Diet high in fat fed as 3 meals a day
Outcomes
Primary Outcome Measures
Effect of meal composition on fractional de novo lipogenesis (fatty acid synthesis)
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
Effect of meal frequency on fractional de novo lipogenesis (fatty acid synthesis)
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.
Full Information
NCT ID
NCT02075710
First Posted
February 26, 2014
Last Updated
May 17, 2022
Sponsor
University of California, San Francisco
Collaborators
Touro University, California
1. Study Identification
Unique Protocol Identification Number
NCT02075710
Brief Title
Dietary Treatment Study of Fat Synthesis and Risk of Cardiovascular Disease
Official Title
Lipogenesis, Lipoprotein Flux, and CVD Risk: Role of Meal Composition and Frequency
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Touro University, California
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Diet, Sugar, Cardiovascular, Lipid
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High sugar/meal feed
Arm Type
Experimental
Arm Description
Diet high in simple sugar fed as two large meals daily
Arm Title
High sugar/nibble
Arm Type
Experimental
Arm Description
Diet high in simple sugar fed as 8 small meals daily
Arm Title
High fat/meal feed
Arm Type
Experimental
Arm Description
Diet high in fat fed as two large meals daily
Arm Title
High fat/nibble
Arm Type
Experimental
Arm Description
Diet high in fat fed as 8 small meals daily
Arm Title
High sugar/3 meals a day
Arm Type
Experimental
Arm Description
Diet high in simple sugar fed as 3 meals a day
Arm Title
High fat/ 3 meals a day
Arm Type
Experimental
Arm Description
Diet high in fat fed as 3 meals a day
Intervention Type
Other
Intervention Name(s)
High sugar/meal feed
Intervention Description
Weight-maintaining diet relatively high in sugar fed as two large meals daily
Intervention Type
Other
Intervention Name(s)
High sugar/nibble
Intervention Description
Weight-maintaining diet relatively high in sugar fed as 8 meals daily
Intervention Type
Other
Intervention Name(s)
High fat/meal feed
Intervention Description
Weight-maintaining diet relatively high in fat fed as two large meals daily
Intervention Type
Other
Intervention Name(s)
High fat/nibble
Intervention Description
Weight-maintaining diet relatively high in fat fed as 8 small meals daily
Intervention Type
Other
Intervention Name(s)
High sugar/ 3 meals a day
Intervention Description
Weight-maintaining diet relatively high in sugar fed as 3 meals daily
Intervention Type
Other
Intervention Name(s)
High fat/ 3 meals a day
Intervention Description
Weight-maintaining diet relatively high in fat fed as 3 meals daily
Primary Outcome Measure Information:
Title
Effect of meal composition on fractional de novo lipogenesis (fatty acid synthesis)
Description
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.
Time Frame
After 10-day dietary period
Secondary Outcome Measure Information:
Title
Effect of meal frequency on fractional de novo lipogenesis (fatty acid synthesis)
Description
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.
Time Frame
After 10-day dietary period
Other Pre-specified Outcome Measures:
Title
Liver fat content
Description
Effects of diet composition or meal frequency on fat stored in the liver.
Liver fat content will be measured non-invasively using magnetic resonance spectroscopy.
Time Frame
After 10-day dietary period
Title
Lipids and lipoproteins in the blood
Description
Effects of diet composition or meal frequency on the types of fats in the bloodstream that might affect risk of heart disease.
The types of fats in the bloodstream will be measured in blood samples collected while the participant is fasting and also during the stable isotope/feeding study of de novo lipogenesis.
Time Frame
After 10-day dietary intervention period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
overweight or obese men and women
ages 20-65 years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Mulligan, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Marc Schwarz, PhD
Organizational Affiliation
Touro University, California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Franciso, San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dietary Treatment Study of Fat Synthesis and Risk of Cardiovascular Disease
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