Overweight and ObesityNCT02075710
Dietary Treatment Study of Fat Synthesis and Risk of Cardiovascular Disease
A study testing High sugar/meal feed, High sugar/nibble and High fat/meal feed in people with Overweight and Obesity, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- High sugar/meal feed, High sugar/nibble and High fat/meal feed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- overweight or obese men and women
- ages 20-65 years
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Franciso, San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Lipogenesis, Lipoprotein Flux, and CVD Risk: Role of Meal Composition and Frequency
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- High sugar/meal feed, High sugar/nibble, High fat/meal feed, High fat/nibble, High sugar/ 3 meals a day
- Keywords
- Diet, Sugar, Cardiovascular, Lipid
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High sugar/meal feedOther
Weight-maintaining diet relatively high in sugar fed as two large meals daily
High sugar/nibbleOther
Weight-maintaining diet relatively high in sugar fed as 8 meals daily
High fat/meal feedOther
Weight-maintaining diet relatively high in fat fed as two large meals daily
High fat/nibbleOther
Weight-maintaining diet relatively high in fat fed as 8 small meals daily
High sugar/ 3 meals a dayOther
Weight-maintaining diet relatively high in sugar fed as 3 meals daily
High fat/ 3 meals a dayOther
Weight-maintaining diet relatively high in fat fed as 3 meals daily
| Study group | Role | What they receive |
|---|---|---|
| High sugar/meal feed | Experimental | Diet high in simple sugar fed as two large meals daily Receives: Other: High sugar/meal feed; Other: High sugar/nibble |
| High sugar/nibble | Experimental | Diet high in simple sugar fed as 8 small meals daily Receives: Other: High sugar/meal feed; Other: High sugar/nibble |
| High fat/meal feed | Experimental | Diet high in fat fed as two large meals daily Receives: Other: High fat/meal feed; Other: High fat/nibble |
| High fat/nibble | Experimental | Diet high in fat fed as 8 small meals daily Receives: Other: High fat/nibble |
| High sugar/3 meals a day | Experimental | Diet high in simple sugar fed as 3 meals a day Receives: Other: High sugar/ 3 meals a day; Other: High fat/ 3 meals a day |
| High fat/ 3 meals a day | Experimental | Diet high in fat fed as 3 meals a day Receives: Other: High sugar/ 3 meals a day; Other: High fat/ 3 meals a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 10-day dietary period
Secondary outcomes (1)
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.
Measured: After 10-day dietary period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionMay 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Touro University, California
- Responsible party
- Sponsor
- Investigators
- Kathleen Mulligan, PhD, Principal investigator, University of California, San FranciscoJean-Marc Schwarz, PhD, Principal investigator, Touro University, California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075710
- Sponsor's protocol ID
- Nibble99
- Status last verified
- Jul 2026
- First submitted
- 26 Feb 2014
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipogenesis, Lipoprotein Flux, and CVD Risk: Role of Meal Composition and Frequency
- ClinicalTrials.gov ID
- NCT02075710
- Acronym / sponsor ID
- Nibble99
- Conditions
- Overweight and Obesity
- Keywords
- Diet, Sugar, Cardiovascular, Lipid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Touro University, California
- Study start
- Jul 2013 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| High sugar/meal feed | Experimental | Other: High sugar/meal feed, Other: High sugar/nibbleDiet high in simple sugar fed as two large meals daily |
| High sugar/nibble | Experimental | Other: High sugar/meal feed, Other: High sugar/nibbleDiet high in simple sugar fed as 8 small meals daily |
| High fat/meal feed | Experimental | Other: High fat/meal feed, Other: High fat/nibbleDiet high in fat fed as two large meals daily |
| High fat/nibble | Experimental | Other: High fat/nibbleDiet high in fat fed as 8 small meals daily |
| High sugar/3 meals a day | Experimental | Other: High sugar/ 3 meals a day, Other: High fat/ 3 meals a dayDiet high in simple sugar fed as 3 meals a day |
| High fat/ 3 meals a day | Experimental | Other: High sugar/ 3 meals a day, Other: High fat/ 3 meals a dayDiet high in fat fed as 3 meals a day |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- overweight or obese men and women
- ages 20-65 years
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High sugar/meal feedWeight-maintaining diet relatively high in sugar fed as two large meals daily | Other | High sugar/meal feed, High sugar/nibble |
| High sugar/nibbleWeight-maintaining diet relatively high in sugar fed as 8 meals daily | Other | High sugar/meal feed, High sugar/nibble |
| High fat/meal feedWeight-maintaining diet relatively high in fat fed as two large meals daily | Other | High fat/meal feed |
| High fat/nibbleWeight-maintaining diet relatively high in fat fed as 8 small meals daily | Other | High fat/meal feed, High fat/nibble |
| High sugar/ 3 meals a dayWeight-maintaining diet relatively high in sugar fed as 3 meals daily | Other | High fat/ 3 meals a day, High sugar/3 meals a day |
| High fat/ 3 meals a dayWeight-maintaining diet relatively high in fat fed as 3 meals daily | Other | High fat/ 3 meals a day, High sugar/3 meals a day |
Primary outcome
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.
1 secondary outcome
Effect of meal frequency on fractional de novo lipogenesis (fatty acid synthesis)
Time frame: After 10-day dietary period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Mulligan, PhD principal investigator
University of California, San Francisco
Jean-Marc Schwarz, PhD principal investigator
Touro University, California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High sugar/meal feed, High sugar/nibble and High fat/meal feed in people with Overweight and Obesity, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of meal composition on fractional de novo lipogenesis (fatty acid synthesis) (time frame: After 10-day dietary period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.