NCT02075710

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

9.4 years

First QC Date

February 26, 2014

Last Update Submit

May 17, 2022

Conditions

Overweight and Obesity

Keywords

DietSugarCardiovascularLipid

Outcome Measures

Primary Outcomes (1)

  • 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.

    After 10-day dietary period

Secondary Outcomes (1)

  • Effect of meal frequency on fractional de novo lipogenesis (fatty acid synthesis)

    After 10-day dietary period

Other Outcomes (2)

  • Liver fat content

    After 10-day dietary period

  • Lipids and lipoproteins in the blood

    After 10-day dietary intervention period

Study Arms (6)

High sugar/meal feed

EXPERIMENTAL

Diet high in simple sugar fed as two large meals daily

Other: High sugar/meal feedOther: High sugar/nibble

High sugar/nibble

EXPERIMENTAL

Diet high in simple sugar fed as 8 small meals daily

Other: High sugar/meal feedOther: High sugar/nibble

High fat/meal feed

EXPERIMENTAL

Diet high in fat fed as two large meals daily

Other: High fat/meal feedOther: High fat/nibble

High fat/nibble

EXPERIMENTAL

Diet high in fat fed as 8 small meals daily

Other: High fat/nibble

High sugar/3 meals a day

EXPERIMENTAL

Diet high in simple sugar fed as 3 meals a day

Other: High sugar/ 3 meals a dayOther: High fat/ 3 meals a day

High fat/ 3 meals a day

EXPERIMENTAL

Diet high in fat fed as 3 meals a day

Other: High sugar/ 3 meals a dayOther: High fat/ 3 meals a day

Interventions

High sugar/meal feedOTHER

Weight-maintaining diet relatively high in sugar fed as two large meals daily

High sugar/meal feedHigh sugar/nibble
High sugar/nibbleOTHER

Weight-maintaining diet relatively high in sugar fed as 8 meals daily

High sugar/meal feedHigh sugar/nibble
High fat/meal feedOTHER

Weight-maintaining diet relatively high in fat fed as two large meals daily

High fat/meal feed
High fat/nibbleOTHER

Weight-maintaining diet relatively high in fat fed as 8 small meals daily

High fat/meal feedHigh fat/nibble
High sugar/ 3 meals a dayOTHER

Weight-maintaining diet relatively high in sugar fed as 3 meals daily

High fat/ 3 meals a dayHigh sugar/3 meals a day
High fat/ 3 meals a dayOTHER

Weight-maintaining diet relatively high in fat fed as 3 meals daily

High fat/ 3 meals a dayHigh sugar/3 meals a day

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • overweight or obese men and women
  • ages 20-65 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Franciso, San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kathleen Mulligan, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Jean-Marc Schwarz, PhD

    Touro University, California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 3, 2014

Study Start

July 1, 2013

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations

US(1)