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Completed

NCT Number: NCT02068885

Framingham State Food Study

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Disease Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Framingham State University

Framingham, Massachusetts, 01702, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feeding study

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Baylor College of Medicine
  • Blue Cross Blue Shield
  • Framingham State University
  • Many Voices Foundation
  • New Balance Foundation
  • Nutrition Science Initiative

Registry information

Official study title

Dietary Composition and Energy Expenditure During Weight-Loss Maintenance

Acronym: (FS)2

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 21, 2014
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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