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Obesity(FS)2NCT02068885

Framingham State Food Study

A study testing Feeding study in people with Obesity and Diabetes, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the effects of dietary composition on energy expenditure and chronic disease risk factors, while also exploring physiological mechanisms underlying these effects. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Diabetes, Cardiovascular Disease
What is being tested?
Feeding study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
1 siteUnited States
Study dates
17 Aug 2014to May 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 65 years
  • BMI ≥ 25 kg/m2
  • Weight ≤ 425 lbs
  • Medical clearance from a primary care provider
  • Plans to matriculate at Framingham State University (campus-based participants: students), work on campus (campus-based participants: faculty and staff), or live in the greater Framingham area (community-based participants) throughout the academic year of enrollment in the study
  • Academic and social clearance from the FSU Office of Enrollment and Student Development (student participants) or willingness to comply with Criminal Offender Record Information (CORI) check and Sex Offender Registry Information (SORI) check (community-based subjects)
Show all 9Show fewer
  • Willingness to eat and drink only the foods and beverages on the study menus during participation, with no food allergies or aversions
  • Willingness to eat in the dining hall
  • Willingness to abstain from consuming alcohol during participation

Who cannot join

  • Change in body weight exceeding ±10% during prior year
  • Recent adherence to a special diet
  • Recent adherence to a vigorous physical activity regimen (e.g., participation in a varsity sport)
  • Chronic use of any medication or dietary supplement that could affect study outcomes
  • Current smoking (1 cigarette in the last week)
  • Heavy baseline alcohol consumption (> 10 drinks/week) or history of binge drinking (≥ 5 drinks in 1 day, anytime in past 6 months)
Show all 10Show fewer
  • Physician diagnosis of a major medical/psychiatric illness or eating disorder
  • Abnormal HgA1c, TSH, BUN, creatinine; hematocrit < 30; ALT > 200% of normal upper limit
  • Plans for a vacation during the study that would preclude adherence to prescribed diet
  • Additional exclusions for female participants: Irregular menstrual cycles; any change in birth control medication during the 3 months prior to enrollment; pregnancy or lactation during the 12 months prior to enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Framingham State University

    Framingham, Massachusetts, 01702

Other trials in United States

About this study

Official title: Dietary Composition and Energy Expenditure During Weight-Loss Maintenance

This study will evaluate the effects of dietary composition on energy expenditure and chronic disease risk factors, while also exploring physiological mechanisms underlying these effects.

Read the detailed description

Many overweight and obese people can lose weight for a few months, but most have difficulty maintaining weight loss over the long term. One explanation for the poor long-term outcome of weight-loss diets relates to behavior, in that motivation to adhere to restrictive regimens typically diminishes with time. An alternative explanation is that weight loss elicits biological adaptations - specifically a decline in energy expenditure and an increase in hunger - that promote weight regain. The purpose of this study is to evaluate the effects of dietary composition on energy expenditure and risk for chronic diseases, while also exploring physiological mechanisms underlying these effects. The study will be performed in collaboration with Framingham State University, providing a novel and feasible method for feeding subjects in dining halls and monitoring compliance.

Following 12±2% weight loss on a standard run-in diet, 150 adults (aged 18 to 65 years) will be randomly assigned to one of three weight-loss maintenance diets controlled for protein content (20% of energy) and varying widely in dietary carbohydrate-to-fat ratio: Low-carbohydrate (20% of energy from carbohydrate, 60% fat), Moderate- carbohydrate (40% carbohydrate, 40% fat), High-carbohydrate (60% carbohydrate, 20% fat). During the weight-loss maintenance phase, energy intake will be adjusted to prevent changes in body weight. The primary outcome will be change in total energy expenditure (indirect calorimetry using stable isotopes) through 20 weeks. Secondary outcomes during weight maintenance will include resting energy expenditure (indirect calorimetry using respiratory gas exchange), physical activity (accelerometry), measures of insulin resistance and skeletal muscle work efficiency, components of the metabolic syndrome, and hormonal and metabolic measures that might inform an understanding of physiological mechanisms. We also will assess weight change during a 2-week ad libitum feeding phase, as an objective measure of dietary effects on hunger. The analytic framework for addressing study hypothesis will be repeated-measures analysis of variance, with adjustment for covariates (sex, race, ethnicity, age, anthropometrics, insulin sensitivity and secretion, obesity-related genes). We also will test each covariate for effect modification (covariate × diet interaction).

Being tested
Feeding study
Keywords
Low carbohydrate diet, Low fat diet, Glycemic index, Weight loss maintenance
Medical subject headings
Obesity, Diabetes Mellitus, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Feeding studyBehavioural

    Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum

Study groups in NCT02068885
Study groupRoleWhat they receive
Low carbohydrate dietExperimentalFeeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Receives: Behavioral: Feeding study
Moderate carbohydrate dietExperimentalFeeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Receives: Behavioral: Feeding study
High carbohydrate dietActive comparatorFeeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Receives: Behavioral: Feeding study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes

    Total energy expenditure (TEE), assessed by indirect calorimetry using stable isotopes

    Total calories burned: Participants each drank about a cup of water containing special tracers which are measurable when they pass out of the body through urine. They provided a urine sample before they drank the water and then about every other day for the next two (2) weeks.

    Change: average (midpoint of test phase, end of test phase) - start of trial

    Measured: Start of Trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

Secondary outcomes (59)

  1. Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange

    Resting energy expenditure, assessed by indirect calorimetry using respiratory gas exchange Calories burned while resting: Participants lied down with head and neck under a clear plastic "bubble," breathing room air. Gases in expired air were collected.

    Change: average (midpoint of test phase, end of test phase) - start of trial

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  2. Physical Activity, Assessed by Accelerometry

    Actigraph Accelerometer Change: average (midpoint of test phase, end of test phase) - start of trial An Actigraph Accelerometer measures movement, similar to a pedometer. Data are reported as counts (divided by 1,000) per day. Each participant wore the the accelerometer on the right hip for 7 days at each time point.

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  3. Skeletal Muscle Work Efficiency

    Efficiency is expressed as percentage ratio of power generated during cycle ergometry (with conversion of Watts to kcal/min using a factor of 0.01433) to energy expenditure above resting.

    Change: end of test phase - start of trial.

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  4. Leptin (Start of Trial)

    Leptin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)).

    Changes (see Outcome 6) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial

    Measured: Start of trial (time of randomization, post-weight loss)

  5. Leptin (% Change)

    Leptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial

    Measured: Change through 20 weeks' weight loss maintenance

  6. Ghrelin (Start of Trial)

    Ghrelin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)).

    Changes (see Outcome 8) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial

    Measured: Start of trial (time of randomization, post-weight loss)

  7. Ghrelin (% Change)

    Ghrelin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial

    Measured: Change through 20 weeks' weight loss maintenance

  8. 1,5-Anhydroglucitol

    Biomeasure of carbohydrate intake Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  9. Glycemic Control, Assessed by HgA1c

    Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial.

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  10. Triglycerides

    Triglyceride levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  11. Body Composition (DXA)

    Body fat, presented as a % of total mass

    Participants each had a special scan (x-ray) to measure their amount of body fat. The special x-ray is called "dual-energy x-ray absorptiometry" (DXA). They were asked to lie still on a table for x-ray pictures.

    Change: end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  12. Glucose

    Glucose level, fasting blood draw Change: end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  13. Change in Lipoprotein Particle Subfraction Distribution

    Lipoprotein insulin resistance (LPIR) score was calculated from triglyceride-rich, high-density, and low-density lipoprotein particle (TRL-P, HDL-P, LDL-P) sizes and subfraction concentrations (large/very large TRL-P, large HDL-P, small LDL-P). LPIR score is quantified on a scale of 0-100. Higher scores indicate worse outcome.

    Change: end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  14. Total Cholesterol

    Change: end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  15. HDL-Cholesterol

    High-density lipoprotein cholesterol Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial.

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  16. Non-HDL-Cholesterol

    Calculated by subtracting HDL-cholesterol from total cholesterol. Change: end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  17. LDL-Cholesterol

    Low-density-lipoprotein cholesterol Change: end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  18. Adiponectin (Start of Trial)

    Total and high molecular weight adiponectin Adiponectin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)).

    Changes (see Outcome 20) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss)

  19. Adiponectin (% Change)

    Adiponeptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial

    Measured: Change through 20 weeks' weight loss maintenance

  20. C-reactive Protein (Start of Trial)

    C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)).

    Changes (see Outcome 22) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss)

  21. C-reactive Protein (% Change)

    C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial

    Measured: Change through 20 weeks' weight loss maintenance

  22. IL-6 (Start of Trial)

    Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)).

    Changes (see Outcome 24) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss)

  23. IL-6 (% Change)

    Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial

    Measured: Change through 20 weeks' weight loss maintenance

  24. Blood Pressure

    Systolic and diastolic blood pressure Change: end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  25. Plasminogen Activator Inhibitor-1 (Start of Trial)

    Plasminogen activator inhibitor-1 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)).

    Changes (see Outcome 27) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss)

  26. Plasminogen Activator Inhibitor-1 (% Change)

    Plasminogen activator inhibitor-1 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial

    Measured: Change through 20 weeks' weight loss maintenance

  27. Fibrinogen

    Change: end of test phase - start of trial

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  28. Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial)

    Insulin level 30 minutes after consuming 75 grams of glucose

    Measured: Start of trial (time of randomization, post-weight loss)

  29. Thyroxine (T4)

    thyroid function test

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  30. Free T4

    free thyroxine, thyroid function test

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  31. Thyroid Stimulating Hormone

    Produced by the pituitary gland in the brain. Tells the thyroid gland to make thyroid hormones.

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  32. Reverse T3

    thyroid function test, inactive form of triiodothyronine (T3) Lifespan Bio kit was used for analysis. The range of this kit is 250 to 5000 pg/mL, which varies from other commercially available kits (about 10-fold greater values).

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  33. Urinary Cortisol Excretion

    cortisol (stress hormone) excreted in the urine over a 24-hour period

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  34. Urinary Catecholamine - Adrenaline

    catecholamine excreted in the urine over 24 hours, also known as epinephrine

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  35. Urinary Catecholamine - Dopamine

    catecholamine excreted in the urine over 24 hours

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  36. Urinary Catecholamine - Noradrenaline

    catecholamine excreted in the urine over 24 hours, also known as norepinephrine

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  37. Insulin Sensitivity (Hepatic), Assessed by Frequently-sampled Oral Glucose Tolerance Test

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  38. Insulin Sensitivity (Systemic), Assessed by Frequently-sampled Oral Glucose Tolerance Test

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  39. Non-esterified Fatty Acids

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  40. Serum Ketones/Ketoacids

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  41. Lactate

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  42. Metabolic Fuel Concentration in Serum (Glucose, Nonesterified Fatty Acids, Ketones/Ketoacids, Lactate)

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  43. Insulin-like Growth Factor 1 (IGF-1)

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  44. IGF Binding Proteins

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  45. Testosterone

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  46. Estradiol

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  47. Luteinizing Hormone

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  48. Follicle Stimulating Hormone

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  49. Body Weight Change During ad Libitum Feeding

    Measured: Ad libitum feeding period (weeks 21 and 22 following randomization)

  50. Gut Microbiome Profile

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  51. Serum Metabolomics Profile

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  52. Change in Cognitive Function Related to Memory

    California Verbal Learning Test - Second Edition [CVLT-II] and Digit Span Test

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  53. Change in Cognitive Function Related to Processing Speed and Executive Function

    Trail Making Test Parts A and B [TMT-A, TMT-B]

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  54. Change in Self-reported Sleep Quality

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  55. Change in Self-reported Depression Measure

    Beck Depression Inventory-II [BDI-II]

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  56. Change in Self-reported Mood/Anxiety

    Mood and Anxiety Symptom Questionnaire [MASQ]

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  57. Change in Self-reported Food Addiction Score

    Yale Food Addiction Scale [YFAS]

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  58. Change in Self-reported Emotional Eating Score

    Emotional Eating Scale [EES]

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

  59. Change in Self-reported Binge Eating Score

    Binge Eating Scale [BES]

    Measured: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2014 (estimated)
  2. Study start17 Aug 2014
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

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
None (open label)
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02068885
Sponsor's protocol ID
IRB-P00009571
Acronym
(FS)2
Status last verified
Mar 2022
First submitted
20 Feb 2014
Last updated
9 Jan 2026
Data monitoring committee
No

Publications

  • Wong JM, Bielak L, Eddy RG, Stone L, Lakin PR, Sandman M, Devlin C, Seger-Shippee L, Wiroll D, Luoto PK, Klein GL, Ludwig DS, Ebbeling CB. An Academia-Industry Partnership for Planning and Executing a Community-Based Feeding Study. Curr Dev Nutr. 2018 Jul 5;2(9):nzy060. doi: 10.1093/cdn/nzy060. eCollection 2018 Sep.

    PubMed 30283914

  • Ebbeling CB, Klein GL, Luoto PK, Wong JMW, Bielak L, Eddy RG, Steltz SK, Devlin C, Sandman M, Hron B, Shimy K, Heymsfield SB, Wolfe RR, Wong WW, Feldman HA, Ludwig DS. A randomized study of dietary composition during weight-loss maintenance: Rationale, study design, intervention, and assessment. Contemp Clin Trials. 2018 Feb;65:76-86. doi: 10.1016/j.cct.2017.12.004. Epub 2017 Dec 9.

    PubMed 29233719

  • Ludwig DS, Greco KF, Ma C, Ebbeling CB. Testing the carbohydrate-insulin model of obesity in a 5-month feeding study: the perils of post-hoc participant exclusions. Eur J Clin Nutr. 2020 Jul;74(7):1109-1112. doi: 10.1038/s41430-020-0658-8. Epub 2020 May 20.

    PubMed 32435054

  • Ebbeling CB, Feldman HA, Klein GL, Wong JMW, Bielak L, Steltz SK, Luoto PK, Wolfe RR, Wong WW, Ludwig DS. Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial. BMJ. 2018 Nov 14;363:k4583. doi: 10.1136/bmj.k4583.

    PubMed 30429127

  • Ebbeling CB, Bielak L, Lakin PR, Klein GL, Wong JMW, Luoto PK, Wong WW, Ludwig DS. Energy Requirement Is Higher During Weight-Loss Maintenance in Adults Consuming a Low- Compared with High-Carbohydrate Diet. J Nutr. 2020 Aug 1;150(8):2009-2015. doi: 10.1093/jn/nxaa150.

    PubMed 32470981

  • Angelidi AM, Bartell E, Huang Y, Zeleznik OA, Estanyol-Torres N, Mi MY, Bhupathiraju SN, Kelly RS, Wittenbecher C, Lasky-Su J, Clish CB, Ludwig DS, Ebbeling CB, Hirschhorn JN. Weight-independent effects of dietary carbohydrate-to-fat ratio on metabolomic profiles: secondary outcomes of a 5-month randomized controlled feeding trial. Nat Commun. 2026 Jan 17;17(1):1662. doi: 10.1038/s41467-026-68353-z.

    PubMed 41547934

  • Wong 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

  • Ebbeling CB, Knapp A, Johnson A, Wong JMW, Greco KF, Ma C, Mora S, Ludwig DS. Effects of a low-carbohydrate diet on insulin-resistant dyslipoproteinemia-a randomized controlled feeding trial. Am J Clin Nutr. 2022 Jan 11;115(1):154-162. doi: 10.1093/ajcn/nqab287.

    PubMed 34582545

Questions about this trial

What is this clinical trial studying?

A study testing Feeding study in people with Obesity and Diabetes, 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 10 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 9 Jan 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?

Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes (time frame: Start of Trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance). 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 NCT02068885, which also lists 8 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 9 Jan 2026.

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Framingham State Food Study (NCT02068885) | AzTrials