Framingham State Food Study ((FS)2)

• ClinicalTrials.gov Identifier: NCT02068885
• Recruitment Status: Completed
• First Posted: February 21, 2014
• Results First Posted: November 4, 2020
• Last Update Posted: July 25, 2022
• Sponsor: Boston Children's Hospital
• Collaborators: Framingham State University; Baylor College of Medicine; Nutrition Science Initiative; New Balance Foundation; Many Voices Foundation; Blue Cross Blue Shield
• Information provided by (Responsible Party): David S. Ludwig, MD, PhD, Boston Children's Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Obesity; Diabetes; Cardiovascular Disease	Behavioral: Feeding study	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 234 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dietary Composition and Energy Expenditure During Weight-Loss Maintenance
• Actual Study Start Date: August 17, 2014
• Actual Primary Completion Date: May 2017
• Actual Study Completion Date: May 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Low carbohydrate diet; Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein	Behavioral: Feeding study; Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
Experimental: Moderate carbohydrate diet; Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein	Behavioral: Feeding study; Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
Active Comparator: High carbohydrate diet; Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein	Behavioral: Feeding study; Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum

Outcome Measures

Primary Outcome Measures :

1. 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 ]

   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

Secondary Outcome Measures :

1. Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]

   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

2. Physical Activity, Assessed by Accelerometry [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
   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.
3. Skeletal Muscle Work Efficiency [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]

   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.

4. Leptin (Start of Trial) [ Time Frame: Start of trial (time of randomization, post-weight loss) ]

   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

5. Leptin (% Change) [ Time Frame: Change through 20 weeks' weight loss maintenance ]
   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
6. Ghrelin (Start of Trial) [ Time Frame: Start of trial (time of randomization, post-weight loss) ]

   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

7. Ghrelin (% Change) [ Time Frame: Change through 20 weeks' weight loss maintenance ]
   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
8. 1,5-Anhydroglucitol [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
   Biomeasure of carbohydrate intake Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial
9. Glycemic Control, Assessed by HgA1c [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
   Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial.
10. Triglycerides [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    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
11. Body Composition (DXA) [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]

    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

12. Glucose [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Glucose level, fasting blood draw Change: end of test phase - start of trial
13. Change in Lipoprotein Particle Subfraction Distribution [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]

    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

14. Total Cholesterol [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Change: end of test phase - start of trial
15. HDL-Cholesterol [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    High-density lipoprotein cholesterol Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial.
16. Non-HDL-Cholesterol [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Calculated by subtracting HDL-cholesterol from total cholesterol. Change: end of test phase - start of trial
17. LDL-Cholesterol [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Low-density-lipoprotein cholesterol Change: end of test phase - start of trial
18. Adiponectin (Start of Trial) [ Time Frame: Start of trial (time of randomization, post-weight loss) ]

    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

19. Adiponectin (% Change) [ Time Frame: Change through 20 weeks' weight loss maintenance ]
    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
20. C-reactive Protein (Start of Trial) [ Time Frame: Start of trial (time of randomization, post-weight loss) ]

    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

21. C-reactive Protein (% Change) [ Time Frame: Change through 20 weeks' weight loss maintenance ]
    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
22. IL-6 (Start of Trial) [ Time Frame: Start of trial (time of randomization, post-weight loss) ]

    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

23. IL-6 (% Change) [ Time Frame: Change through 20 weeks' weight loss maintenance ]
    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
24. Blood Pressure [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Systolic and diastolic blood pressure Change: end of test phase - start of trial
25. Plasminogen Activator Inhibitor-1 (Start of Trial) [ Time Frame: Start of trial (time of randomization, post-weight loss) ]

    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

26. Plasminogen Activator Inhibitor-1 (% Change) [ Time Frame: Change through 20 weeks' weight loss maintenance ]
    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
27. Fibrinogen [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Change: end of test phase - start of trial
28. Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) [ Time Frame: Start of trial (time of randomization, post-weight loss) ]
    Insulin level 30 minutes after consuming 75 grams of glucose
29. Thyroxine (T4) [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    thyroid function test
30. Free T4 [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    free thyroxine, thyroid function test
31. Thyroid Stimulating Hormone [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Produced by the pituitary gland in the brain. Tells the thyroid gland to make thyroid hormones.
32. Reverse T3 [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    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).
33. Urinary Cortisol Excretion [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    cortisol (stress hormone) excreted in the urine over a 24-hour period
34. Urinary Catecholamine - Adrenaline [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    catecholamine excreted in the urine over 24 hours, also known as epinephrine
35. Urinary Catecholamine - Dopamine [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    catecholamine excreted in the urine over 24 hours
36. Urinary Catecholamine - Noradrenaline [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    catecholamine excreted in the urine over 24 hours, also known as norepinephrine
37. Insulin Sensitivity (Hepatic), Assessed by Frequently-sampled Oral Glucose Tolerance Test [ Time Frame: 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 [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
39. Non-esterified Fatty Acids [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
40. Serum Ketones/Ketoacids [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
41. Lactate [ Time Frame: 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) [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
43. Insulin-like Growth Factor 1 (IGF-1) [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
44. IGF Binding Proteins [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
45. Testosterone [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
46. Estradiol [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
47. Luteinizing Hormone [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
48. Follicle Stimulating Hormone [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
49. Body Weight Change During ad Libitum Feeding [ Time Frame: Ad libitum feeding period (weeks 21 and 22 following randomization) ]
50. Gut Microbiome Profile [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
51. Serum Metabolomics Profile [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
52. Change in Cognitive Function Related to Memory [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    California Verbal Learning Test - Second Edition [CVLT-II] and Digit Span Test
53. Change in Cognitive Function Related to Processing Speed and Executive Function [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Trail Making Test Parts A and B [TMT-A, TMT-B]
54. Change in Self-reported Sleep Quality [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
55. Change in Self-reported Depression Measure [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Beck Depression Inventory-II [BDI-II]
56. Change in Self-reported Mood/Anxiety [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Mood and Anxiety Symptom Questionnaire [MASQ]
57. Change in Self-reported Food Addiction Score [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Yale Food Addiction Scale [YFAS]
58. Change in Self-reported Emotional Eating Score [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Emotional Eating Scale [EES]
59. Change in Self-reported Binge Eating Score [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Binge Eating Scale [BES]

Other Outcome Measures:

1. Effect Modification by Insulin Secretion of Metabolic Responses to Diet [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
   Effect modifier: Insulin level 30 minutes into an standard OGTT (Insulin-30) Outcome: Total Energy Expenditure Tertiles: Pre-weight-loss Insulin-30 (Low, Moderate, High) Change: average (midpoint of test phase, end of test phase) - start of trial
2. Effect Modification by Insulin Resistance of Metabolic Responses to Diet [ Time Frame: Start of (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
3. Effect Modification by Amylase Gene Copy Number [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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)
• 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

Exclusion Criteria:

• 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)
• 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

Contacts and Locations

Locations

United States, Massachusetts

Framingham State University

Framingham, Massachusetts, United States, 01702

Sponsors and Collaborators

Boston Children's Hospital

Framingham State University

Baylor College of Medicine

Nutrition Science Initiative

New Balance Foundation

Many Voices Foundation

Blue Cross Blue Shield

Investigators

• Study Director: Gloria Klein, MS, RD; Boston Children's Hospital
• Principal Investigator: Cara B Ebbeling, PhD; Boston Children's Hospital
• Principal Investigator: David S Ludwig, MD, PhD; Boston Children's Hospital

  Study Documents (Full-Text)

Documents provided by David S. Ludwig, MD, PhD, Boston Children's Hospital:

Study Protocol  [PDF] June 14, 2017

Statistical Analysis Plan  [PDF] June 14, 2017

More Information

Publications of Results:

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. Erratum In: BMJ. 2020 Nov 3;371:m4264.

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.

Other 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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. Erratum In: Am J Clin Nutr. 2022 Jan 11;115(1):310.

• Responsible Party: David S. Ludwig, MD, PhD, Director, Obesity Prevention Center, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT02068885
• Other Study ID Numbers: IRB-P00009571
• First Posted: February 21, 2014
• Results First Posted: November 4, 2020
• Last Update Posted: July 25, 2022
• Last Verified: March 2022

Keywords provided by David S. Ludwig, MD, PhD, Boston Children's Hospital:

Low carbohydrate diet; Low fat diet; Glycemic index; Weight loss maintenance

Additional relevant MeSH terms:

Cardiovascular Diseases