ObesityNCT03394664
FB4 (Framingham, Boston, Bloomington, Birmingham, and Baylor)
A study testing Feeding Study in people with Obesity, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study will evaluate the effects of dietary carbohydrate and sugar consumption, independent of energy content, on body fatness and metabolism in a rigorous feeding study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Feeding Study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2018to 3 May 2020
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 50 years
- BMI ≥ 27 kg/m2
- Weight ≤ 350 lb
- Medical clearance from a primary care provider
- Willingness to follow a VLC weight-loss diet
- Willingness to reside in a research unit for 3 months and eat/drink only provided study foods and beverages
Show all 9Show fewer
- No major food allergies or aversions
- Willingness to obtain seasonal flu shot or provide documentation of flu shot for current flu season (winter/spring cohort only)
- Willingness to discuss work options (e.g., remote work) with employer, and make appropriate arrangements prior to the Residential phase.
Who cannot join
- Change in body weight ≥ 10% during prior 6 months
- Specialized diets (e.g., for medical or religious reasons)
- Chronic use of any medication or dietary supplement that could affect study outcomes (e.g., insulin, metformin, thyroxine)
- Current smoking (1 cigarette in the last week)
- Greater than moderate alcohol consumption (> 14 drinks/wk) or history of binge drinking (≥5 drinks in 1 day within past 6 months)
- Physician diagnosis of a major medical illness or eating disorder
Show all 16Show fewer
- History of kidney stones
- Laboratory tests: ALT>2x upper limit; abnormal HgA1c; abnormal TSH; abnormal creatinine; abnormal uric acid (using the male upper limit for both sexes)
- Failed criminal offender background check or sex offender background check
- Use of recreational drugs
- Current diagnosis or history of kidney stones, gout, or gall stones; or removal of gall bladder
- Exercise restrictions or at high risk for complications during exercise
- Female-specific exclusion criteria:
- Menopausal
- Any change in birth control medication during the 3 months prior to enrollment
- Pregnancy or lactation during the 12 months prior to enrollment, or intent to become pregnant during study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Conference Center and Inn
Ashland, Massachusetts, 01721
About this study
Official title: Macronutrients and Body Fat Accumulation: A Mechanistic Feeding Study
This study will evaluate the effects of dietary carbohydrate and sugar consumption, independent of energy content, on body fatness and metabolism in a rigorous feeding study.
Read the detailed description
Many people with obesity can lose weight for a few months, but most have difficulty maintaining weight loss over the long term. Extensive research has shown that weight loss elicits biological adaptations - including a decline in energy expenditure and an increase in hunger - that promote weight regain. However, this observation leaves unanswered why average body weight has recently increased among populations that are mostly genetically stable. According to the Carbohydrate-Insulin Model, increased consumption of processed carbohydrates during the low-fat diet era of the last 40 years has raised the average body weight being defended by biological mechanisms on a population basis. Specifically, the investigators hypothesize that diets high in total carbohydrate (with or without added sugar) acting through increased insulin secretion, alter substrate partitioning toward storage in body fat, leading to increased hunger, slowing metabolism, and accumulation of body fat.
To test this hypothesis, the investigators plan a randomized-controlled feeding study involving 125 adults with obesity. During the run-in phase, participants will be given a hypocaloric very-low-carbohydrate (VLC) diet, with adjustment of energy intake to produce 15 ± 3% weight loss over 3 to 4 months on an outpatient basis. After weight stabilization, participants will be admitted to a residential center for 13 weeks. During the first 3 weeks, energy intake and expenditure will be closely monitored during weight-loss maintenance. Then, energy intake will be individually "locked" at levels equal to energy expenditure and participants will be administered one of three randomly-assigned test diets for 10 weeks. The test diets include VLC, High Carbohydrate-Low Sugar (HC-LS), and High Carbohydrate-High Sugar (HC-HS).
- Conditions
- Obesity
- Being tested
- Feeding Study
- Keywords
- Body composition, Feeding study, Ketogenic diet, Weight loss, Energy Expenditure
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding StudyBehavioural
Also called weight loss, weight-loss maintenance
Food provision throughout the study: 1) Run-In Phase (VLC diet, weight loss); 2) Residential Phase (3 different test diets, weight-loss maintenance).
| Study group | Role | What they receive |
|---|---|---|
| Very-Low Carbohydrate Diet | Experimental | Feeding study. Dietary composition (approximately): 75% fat Receives: Behavioral: Feeding Study |
| High-Carbohydrate Low-Sugar Diet | Experimental | Feeding study. Dietary composition (approximately): 25% fat 0% added sugars. Receives: Behavioral: Feeding Study |
| High-Carbohydrate High-Sugar Diet | Experimental | Feeding study. Dietary composition (approximately): 25% fat, 20% added sugars. Receives: Behavioral: Feeding Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat mass
Body composition assessed using a multi-component model
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Secondary outcomes (33)
Lean body mass
Assessed using a multi-component model (difference between total body mass and fat mass)
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Body weight
Anthropometrics, assessed by calibrated scale, in kilograms (kg)
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Total energy expenditure (TEE)
Assessed using doubly labeled water methodology
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Resting energy expenditure (REE)
Assessed by indirect calorimetry using respiratory gas exchange methodology with a ventilated hood system
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Physical activity level, (moderate to vigorous)
Total minutes of moderate- to vigorous-intensity physical activity, assessed by accelerometry
Measured: Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome
Insulin sensitivity
Assessed by frequently-sampled oral glucose tolerance test [OGTT], calculated using plasma insulin and glucose values
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Insulin secretion
Assessed by frequently-sampled oral glucose tolerance test [OGTT], using plasma insulin at 30 minutes following the dose of dextrose
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Glycemic control
Hemoglobin A1c [HbA1c]
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Total cholesterol
Chronic disease risk factor
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
HDL-cholesterol
Chronic disease risk factor
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
LDL-cholesterol
Chronic disease risk factor
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Non-HDL cholesterol
Chronic disease risk factor
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Triglycerides
Chronic disease risk factor
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Plasminogen Activator Inhibitor-1 [PAI-1]
Indicator of coagulopathy
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
High-sensitivity C-reactive protein [hsCRP]
Indicator of chronic inflammation
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Uric acid
Indicator of risk for kidney stones, measured in blood
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Systolic blood pressure
Assessed by auscultation, mmHg
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Diastolic blood pressure
Assessed by auscultation, mmHg
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Thyroxine (T4)
Thyroid function
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Free T4
Thyroid function
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Thyroid stimulating hormone [TSH]
Thyroid function
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Insulin-like growth factor-1 [IGF-1]
Growth hormone action
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Urine cortisol
Stress hormone, assessed using 24-hour urine collection
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Urine catecholamines
Stress hormone, assessed using 24-hour urine collection
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Leptin
Adipokine
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Total Adiponectin
Adipokine
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
High-molecular weight adiponectin
Adipokine
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Sleep
Total sleep time, sleep onset latency, wake after sleep onset, and sleep efficiency, assessed by accelerometry
Measured: Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome
Blood glucose
Assessed by continuous glucose monitoring (CGM)
Measured: Measurements made daily during residential phase (0 to 10 weeks) and integrated into a unified outcome
Ghrelin
Hormonal Control of Appetite
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Body Circumference
Assessed using a 3D body scan
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Post-prandial energy expenditure and respiratory quotient
Optional testing, assessed by indirect calorimetry using respiratory gas exchange
Measured: Single assessment in weeks 6 to 8 of residential study
Activation of insulin signaling pathways
Assessed by immunohistochemistry of phosphorylated insulin receptor and signaling proteins
Measured: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start9 May 2018
- Primary completion3 May 2020
- Study completion3 May 2020
Why it stopped: The FB4 trial has been terminated due to COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, University of Alabama at Birmingham, Framingham State University, Baylor University
- Responsible party
- Principal investigator, David S. Ludwig, MD, PhD, Boston Children's Hospital
- Investigators
- David S Ludwig, MD, PhD, Principal investigator, Boston Children's HospitalDavid B Allison, PhD, Principal investigator, Indiana University, BloomingtonCara B Ebbeling, PhD, Study director, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394664
- Sponsor's protocol ID
- IRB-P00026977
- Status last verified
- Oct 2020
- First submitted
- 29 Dec 2017
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ludwig DS, Friedman MI. Increasing adiposity: consequence or cause of overeating? JAMA. 2014 Jun 4;311(21):2167-8. doi: 10.1001/jama.2014.4133. No abstract available.
PubMed 24839118Ebbeling CB, Swain JF, Feldman HA, Wong WW, Hachey DL, Garcia-Lago E, Ludwig DS. Effects of dietary composition on energy expenditure during weight-loss maintenance. JAMA. 2012 Jun 27;307(24):2627-34. doi: 10.1001/jama.2012.6607.
PubMed 22735432Dantas E, Shi Y, Kim J, Murthy A, Emmanuelli A, Li S, Perrier T, Ahmed T, Nathoo I, Echeverria CE, Wang Y, Abdallah O, Janowitz T, Hurd MA, Suzuki-Kemuriyama N, Ebbeling CB, Allison DB, Hopkins BD, Cantley LC, Ludwig DS, Goncalves MD. Effects of refined carbohydrates on immune markers after weight loss on a very-low-carbohydrate diet: A randomized controlled feeding trial. Cell Press Blue. 2026 Sep 21;1(6):100122. doi: 10.1016/j.cpblue.2026.100122. Epub 2026 Sep 9.
PubMed 42899010Wong MC, Bennett JP, Leong LT, Tian IY, Liu YE, Kelly NN, McCarthy C, Wong JMW, Ebbeling CB, Ludwig DS, Irving BA, Scott MC, Stampley J, Davis B, Johannsen N, Matthews R, Vincellette C, Garber AK, Maskarinec G, Weiss E, Rood J, Varanoske AN, Pasiakos SM, Heymsfield SB, Shepherd JA. Monitoring body composition change for intervention studies with advancing 3D optical imaging technology in comparison to dual-energy X-ray absorptiometry. Am J Clin Nutr. 2023 Apr;117(4):802-813. doi: 10.1016/j.ajcnut.2023.02.006. Epub 2023 Feb 14.
PubMed 36796647Jansen LT, Yang N, Wong JMW, Mehta T, Allison DB, Ludwig DS, Ebbeling CB. Prolonged Glycemic Adaptation Following Transition From a Low- to High-Carbohydrate Diet: A Randomized Controlled Feeding Trial. Diabetes Care. 2022 Mar 1;45(3):576-584. doi: 10.2337/dc21-1970.
PubMed 35108378Wong JMW, Yu S, Ma C, Mehta T, Dickinson SL, Allison DB, Heymsfield SB, Ebbeling CB, Ludwig DS. Stimulated Insulin Secretion Predicts Changes in Body Composition Following Weight Loss in Adults with High BMI. J Nutr. 2022 Mar 3;152(3):655-662. doi: 10.1093/jn/nxab315.
PubMed 34587231
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macronutrients and Body Fat Accumulation: A Mechanistic Feeding Study
- ClinicalTrials.gov ID
- NCT03394664
- Acronym / sponsor ID
- IRB-P00026977
- Conditions
- Obesity
- Keywords
- Body composition, Feeding study, Ketogenic diet, Weight loss, Energy Expenditure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The FB4 trial has been terminated due to COVID-19.
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Indiana University, University of Alabama at Birmingham, Framingham State University, Baylor University
- Study start
- 9 May 2018 (actual)
- Primary completion
- 3 May 2020 (actual)
- Study completion
- 3 May 2020 (actual)
- First posted
- 9 Jan 2018 (actual)
- 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.
This study will evaluate the effects of dietary carbohydrate and sugar consumption, independent of energy content, on body fatness and metabolism in a rigorous feeding study.
Detailed description
Many people with obesity can lose weight for a few months, but most have difficulty maintaining weight loss over the long term. Extensive research has shown that weight loss elicits biological adaptations - including a decline in energy expenditure and an increase in hunger - that promote weight regain. However, this observation leaves unanswered why average body weight has recently increased among populations that are mostly genetically stable. According to the Carbohydrate-Insulin Model, increased consumption of processed carbohydrates during the low-fat diet era of the last 40 years has raised the average body weight being defended by biological mechanisms on a population basis. Specifically, the investigators hypothesize that diets high in total carbohydrate (with or without added sugar) acting through increased insulin secretion, alter substrate partitioning toward storage in body fat, leading to increased hunger, slowing metabolism, and accumulation of body fat.
To test this hypothesis, the investigators plan a randomized-controlled feeding study involving 125 adults with obesity. During the run-in phase, participants will be given a hypocaloric very-low-carbohydrate (VLC) diet, with adjustment of energy intake to produce 15 ± 3% weight loss over 3 to 4 months on an outpatient basis. After weight stabilization, participants will be admitted to a residential center for 13 weeks. During the first 3 weeks, energy intake and expenditure will be closely monitored during weight-loss maintenance. Then, energy intake will be individually "locked" at levels equal to energy expenditure and participants will be administered one of three randomly-assigned test diets for 10 weeks. The test diets include VLC, High Carbohydrate-Low Sugar (HC-LS), and High Carbohydrate-High Sugar (HC-HS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Very-Low Carbohydrate Diet | Experimental | Behavioral: Feeding StudyFeeding study. Dietary composition (approximately): 75% fat |
| High-Carbohydrate Low-Sugar Diet | Experimental | Behavioral: Feeding StudyFeeding study. Dietary composition (approximately): 25% fat 0% added sugars. |
| High-Carbohydrate High-Sugar Diet | Experimental | Behavioral: Feeding StudyFeeding study. Dietary composition (approximately): 25% fat, 20% added sugars. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Aged 18 to 50 years
- BMI ≥ 27 kg/m2
- Weight ≤ 350 lb
- Medical clearance from a primary care provider
- Willingness to follow a VLC weight-loss diet
Key exclusion criteria (16 listed)
- Change in body weight ≥ 10% during prior 6 months
- Specialized diets (e.g., for medical or religious reasons)
- Chronic use of any medication or dietary supplement that could affect study outcomes (e.g., insulin, metformin, thyroxine)
- Current smoking (1 cigarette in the last week)
- Greater than moderate alcohol consumption (> 14 drinks/wk) or history of binge drinking (≥5 drinks in 1 day within past 6 months)
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 |
|---|---|---|
| Feeding StudyAlso: weight loss, weight-loss maintenanceFood provision throughout the study: 1) Run-In Phase (VLC diet, weight loss); 2) Residential Phase (3 different test diets, weight-loss maintenance). | Behavioural | High-Carbohydrate High-Sugar Diet, High-Carbohydrate Low-Sugar Diet, Very-Low Carbohydrate Diet |
Primary outcome
Body fat mass
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Body composition assessed using a multi-component model
33 secondary outcomes
Lean body mass
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Body weight
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Total energy expenditure (TEE)
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Resting energy expenditure (REE)
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Physical activity level, (moderate to vigorous)
Time frame: Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome
Insulin sensitivity
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Insulin secretion
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Glycemic control
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Total cholesterol
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
HDL-cholesterol
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
LDL-cholesterol
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Non-HDL cholesterol
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Triglycerides
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Plasminogen Activator Inhibitor-1 [PAI-1]
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
High-sensitivity C-reactive protein [hsCRP]
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Uric acid
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Systolic blood pressure
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Diastolic blood pressure
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Thyroxine (T4)
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Free T4
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Thyroid stimulating hormone [TSH]
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Insulin-like growth factor-1 [IGF-1]
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Urine cortisol
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Urine catecholamines
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Leptin
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Total Adiponectin
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
High-molecular weight adiponectin
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Sleep
Time frame: Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome
Blood glucose
Time frame: Measurements made daily during residential phase (0 to 10 weeks) and integrated into a unified outcome
Ghrelin
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Body Circumference
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Post-prandial energy expenditure and respiratory quotient
Time frame: Single assessment in weeks 6 to 8 of residential study
Activation of insulin signaling pathways
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Results and safety
The study was stopped early (reason given: The FB4 trial has been terminated due to COVID-19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Background: PubMed 24839118Ludwig DS, Friedman MI. Increasing adiposity: consequence or cause of overeating? JAMA. 2014 Jun 4;311(21):2167-8. doi: 10.1001/jama.2014.4133. No abstract available.
- Background: PubMed 22735432Ebbeling CB, Swain JF, Feldman HA, Wong WW, Hachey DL, Garcia-Lago E, Ludwig DS. Effects of dietary composition on energy expenditure during weight-loss maintenance. JAMA. 2012 Jun 27;307(24):2627-34. doi: 10.1001/jama.2012.6607.
- Derived from this study: PubMed 42899010Dantas E, Shi Y, Kim J, Murthy A, Emmanuelli A, Li S, Perrier T, Ahmed T, Nathoo I, Echeverria CE, Wang Y, Abdallah O, Janowitz T, Hurd MA, Suzuki-Kemuriyama N, Ebbeling CB, Allison DB, Hopkins BD, Cantley LC, Ludwig DS, Goncalves MD. Effects of refined carbohydrates on immune markers after weight loss on a very-low-carbohydrate diet: A randomized controlled feeding trial. Cell Press Blue. 2026 Sep 21;1(6):100122. doi: 10.1016/j.cpblue.2026.100122. Epub 2026 Sep 9.
- Derived from this study: PubMed 36796647Wong MC, Bennett JP, Leong LT, Tian IY, Liu YE, Kelly NN, McCarthy C, Wong JMW, Ebbeling CB, Ludwig DS, Irving BA, Scott MC, Stampley J, Davis B, Johannsen N, Matthews R, Vincellette C, Garber AK, Maskarinec G, Weiss E, Rood J, Varanoske AN, Pasiakos SM, Heymsfield SB, Shepherd JA. Monitoring body composition change for intervention studies with advancing 3D optical imaging technology in comparison to dual-energy X-ray absorptiometry. Am J Clin Nutr. 2023 Apr;117(4):802-813. doi: 10.1016/j.ajcnut.2023.02.006. Epub 2023 Feb 14.
- Derived from this study: PubMed 35108378Jansen LT, Yang N, Wong JMW, Mehta T, Allison DB, Ludwig DS, Ebbeling CB. Prolonged Glycemic Adaptation Following Transition From a Low- to High-Carbohydrate Diet: A Randomized Controlled Feeding Trial. Diabetes Care. 2022 Mar 1;45(3):576-584. doi: 10.2337/dc21-1970.
- Derived from this study: PubMed 34587231Wong JMW, Yu S, Ma C, Mehta T, Dickinson SL, Allison DB, Heymsfield SB, Ebbeling CB, Ludwig DS. Stimulated Insulin Secretion Predicts Changes in Body Composition Following Weight Loss in Adults with High BMI. J Nutr. 2022 Mar 3;152(3):655-662. doi: 10.1093/jn/nxab315.
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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.
David S Ludwig, MD, PhD principal investigator
Boston Children's Hospital
David B Allison, PhD principal investigator
Indiana University, Bloomington
Cara B Ebbeling, PhD study director
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding Study in people with Obesity, run by Boston Children's Hospital 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 9 inclusion and 16 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: stopped early, as of the sponsor's last update on 18 Jun 2021. 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 was stopped early (reason given: The FB4 trial has been terminated due to COVID-19.). Results are not available in the source record.
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?
Body fat mass (time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03394664, which also lists 6 linked publications.
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 18 Jun 2021.