Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dietary Treatment Study of Fat Synthesis and Risk of Cardiovascular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02075710
Recruitment Status : Recruiting
First Posted : March 3, 2014
Last Update Posted : May 6, 2020
Sponsor:
Collaborator:
Touro University, California
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Other: High sugar/meal feed Other: High sugar/nibble Other: High fat/meal feed Other: High fat/nibble Other: High sugar/ 3 meals a day Other: High fat/ 3 meals a day Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Lipogenesis, Lipoprotein Flux, and CVD Risk: Role of Meal Composition and Frequency
Study Start Date : July 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: High sugar/meal feed
Diet high in simple sugar fed as two large meals daily
Other: High sugar/meal feed
Weight-maintaining diet relatively high in sugar fed as two large meals daily

Other: High sugar/nibble
Weight-maintaining diet relatively high in sugar fed as 8 meals daily

Experimental: High sugar/nibble
Diet high in simple sugar fed as 8 small meals daily
Other: High sugar/meal feed
Weight-maintaining diet relatively high in sugar fed as two large meals daily

Other: High sugar/nibble
Weight-maintaining diet relatively high in sugar fed as 8 meals daily

Experimental: High fat/meal feed
Diet high in fat fed as two large meals daily
Other: High fat/meal feed
Weight-maintaining diet relatively high in fat fed as two large meals daily

Other: High fat/nibble
Weight-maintaining diet relatively high in fat fed as 8 small meals daily

Experimental: High fat/nibble
Diet high in fat fed as 8 small meals daily
Other: High fat/nibble
Weight-maintaining diet relatively high in fat fed as 8 small meals daily

Experimental: High sugar/3 meals a day
Diet high in simple sugar fed as 3 meals a day
Other: High sugar/ 3 meals a day
Weight-maintaining diet relatively high in sugar fed as 3 meals daily

Other: High fat/ 3 meals a day
Weight-maintaining diet relatively high in fat fed as 3 meals daily

Experimental: High fat/ 3 meals a day
Diet high in fat fed as 3 meals a day
Other: High sugar/ 3 meals a day
Weight-maintaining diet relatively high in sugar fed as 3 meals daily

Other: High fat/ 3 meals a day
Weight-maintaining diet relatively high in fat fed as 3 meals daily




Primary Outcome Measures :
  1. Effect of meal composition on fractional de novo lipogenesis (fatty acid synthesis) [ Time Frame: 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 :
  1. Effect of meal frequency on fractional de novo lipogenesis (fatty acid synthesis) [ Time Frame: 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.



Other Outcome Measures:
  1. Liver fat content [ Time Frame: After 10-day dietary period ]

    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.


  2. Lipids and lipoproteins in the blood [ Time Frame: After 10-day dietary intervention period ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075710


Contacts
Layout table for location contacts
Contact: Kathleen Mulligan, PhD 415 206 5882 kathleen.mulligan@ucsf.edu
Contact: Michael J. Wen, MS 415 206 5532 mwen@medsfgh.ucsf.edu

Locations
Layout table for location information
United States, California
University of California, San Franciso, San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Principal Investigator: Kathleen Mulligan, PhD         
Sponsors and Collaborators
University of California, San Francisco
Touro University, California
Investigators
Layout table for investigator information
Principal Investigator: Kathleen Mulligan, PhD University of California, San Francisco
Principal Investigator: Jean-Marc Schwarz, PhD Touro University, California
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02075710    
Other Study ID Numbers: Nibble99
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Keywords provided by University of California, San Francisco:
Diet
Sugar
Cardiovascular
Lipid
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight
Signs and Symptoms