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Framingham State Food Study ((FS)2)

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ClinicalTrials.gov Identifier: NCT02068885
Recruitment Status : Completed
First Posted : February 21, 2014
Results First Posted : November 4, 2020
Last Update Posted : February 16, 2021
Sponsor:
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

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).

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

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




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


  4. 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 55) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial


  5. 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

  6. 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.

  7. Total Cholesterol [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  8. 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.

  9. LDL-cholesterol [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  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. Plasminogen Activator Inhibitor-1 [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  12. C-reactive Protein [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  13. IL-6 [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Interleukin-6, marker of inflammation

  14. Fibrinogen [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  15. Adiponectin [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  16. Blood Pressure [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  17. 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 ]
  18. 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 ]
  19. Glucose [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  20. Non-esterified Fatty Acids [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  21. Serum Ketones/Ketoacids [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  22. Lactate [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  23. 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 ]
  24. Body Composition (4-compartment Model) [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  25. Thyroid Stimulating Hormone [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  26. Thyroxine (T4) [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  27. Reverse T3 [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  28. Free T4 [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  29. Insulin-like Growth Factor 1 (IGF-1) [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  30. IGF Binding Proteins [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  31. Testosterone [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  32. Estradiol [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  33. Luteinizing Hormone [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  34. Follicle Stimulating Hormone [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  35. Urinary Cortisol Excretion [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  36. Urinary Catecholamine Excretion [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  37. Gut Microbiome Profile [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  38. Serum Metabolomics Profile [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  39. Body Weight Change During ad Libitum Feeding [ Time Frame: Ad libitum feeding period (weeks 21 and 22 following randomization) ]
  40. Non-HDL-cholesterol [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  41. 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.


  42. Change in Lipoprotein Particle Subfraction Distribution [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  43. Change in Self-reported Sleep Quality [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  44. 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]

  45. 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]

  46. Change in Self-reported Food Addition Score [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
    Yale Food Addiction Scale [YFAS]

  47. 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]

  48. 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]

  49. 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

  50. 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]

  51. Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  52. C-Peptide [ Time Frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance ]
  53. 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

  54. 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


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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068885


Locations
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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
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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:
Statistical Analysis Plan  [PDF] June 14, 2017
Study Protocol  [PDF] June 14, 2017

Publications of Results:
Other Publications:
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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    Key Record Dates
Results First Posted: November 4, 2020
Last Update Posted: February 16, 2021
Last Verified: January 2021
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:
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Cardiovascular Diseases