Obesity Clinical Trial
Official title:
Macronutrients and Body Fat Accumulation: A Mechanistic Feeding Study
NCT number | NCT03394664 |
Other study ID # | IRB-P00026977 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 9, 2018 |
Est. completion date | May 3, 2020 |
Verified date | October 2020 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the effects of dietary carbohydrate and sugar consumption, independent of energy content, on body fatness and metabolism in a rigorous feeding study.
Status | Terminated |
Enrollment | 166 |
Est. completion date | May 3, 2020 |
Est. primary completion date | May 3, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Aged 18 to 50 years - BMI = 27 kg/m2 - Weight = 350 lb - Medical clearance from a primary care provider - Willingness to follow a VLC weight-loss diet - Willingness to reside in a research unit for 3 months and eat/drink only provided study foods and beverages - No major food allergies or aversions - Willingness to obtain seasonal flu shot or provide documentation of flu shot for current flu season (winter/spring cohort only) - Willingness to discuss work options (e.g., remote work) with employer, and make appropriate arrangements prior to the Residential phase. Exclusion Criteria: - Change in body weight = 10% during prior 6 months - Specialized diets (e.g., for medical or religious reasons) - Chronic use of any medication or dietary supplement that could affect study outcomes (e.g., insulin, metformin, thyroxine) - Current smoking (1 cigarette in the last week) - Greater than moderate alcohol consumption (> 14 drinks/wk) or history of binge drinking (=5 drinks in 1 day within past 6 months) - Physician diagnosis of a major medical illness or eating disorder - History of kidney stones - Laboratory tests: ALT>2x upper limit; abnormal HgA1c; abnormal TSH; abnormal creatinine; abnormal uric acid (using the male upper limit for both sexes) - Failed criminal offender background check or sex offender background check - Use of recreational drugs - Current diagnosis or history of kidney stones, gout, or gall stones; or removal of gall bladder - Exercise restrictions or at high risk for complications during exercise Female-specific exclusion criteria: - Menopausal - Any change in birth control medication during the 3 months prior to enrollment - Pregnancy or lactation during the 12 months prior to enrollment, or intent to become pregnant during study participation |
Country | Name | City | State |
---|---|---|---|
United States | Warren Conference Center and Inn | Ashland | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | Baylor University, Framingham State University, Indiana University, University of Alabama at Birmingham |
United States,
Ebbeling CB, Swain JF, Feldman HA, Wong WW, Hachey DL, Garcia-Lago E, Ludwig DS. Effects of dietary composition on energy expenditure during weight-loss maintenance. JAMA. 2012 Jun 27;307(24):2627-34. doi: 10.1001/jama.2012.6607. — View Citation
Ludwig DS, Friedman MI. Increasing adiposity: consequence or cause of overeating? JAMA. 2014 Jun 4;311(21):2167-8. Erratum in: JAMA. 2014 Jun 4;311(21):2168. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 1,5-anhydroglucitol (1,5-AG) | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Lipoprotein particle subfraction distribution | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Fibrinogen | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Interleukin-6 (IL-6) | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Reverse triiodothyronine (rT3) | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Insulin-like growth factor-binding protein 3 (IGF-BP3) | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Luteinizing hormone (LH) | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Follicle stimulating hormone (FSH) | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Estradiol (E2) | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Testosterone (TST, total) | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Testosterone (TST, free) | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Metabolomics profile | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Biomarker of cholesterol synthesis | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Biomarker of cholesterol absorption | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | MicroRNA | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Gut microbiome | Possible future analyses of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Demographics (mediator/modifier) | Baseline covariate | Pre-weight loss baseline | |
Other | Body composition (mediator/modifier) | Baseline covariate | Pre-weight loss baseline | |
Other | Measure of glucose homeostasis (insulin-30) (mediator/modifier) | Baseline covariate | Pre-weight loss baseline | |
Other | Measure of glucose homeostasis (insulin sensitivity) (mediator/modifier) | Baseline covariate | Pre-weight loss baseline | |
Other | Measure of glucose homeostasis (glycemic control) (mediator/modifier) | Baseline covariate | Pre-weight loss baseline | |
Other | Obesity related genetic risk (mediator/modifier) | Baseline covariate | Pre-weight loss baseline | |
Other | Body composition (mediator/modifier) | Time varying covariate | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Measure of glucose homeostasis (insulin-30) (mediator/modifier) | Time varying covariate | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Measure of glucose homeostasis (insulin sensitivity) (mediator/modifier) | Time varying covariate | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Measure of glucose homeostasis (glycemic control) (mediator/modifier) | Time varying covariate | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Physical activity level (moderate to vigorous) (mediator/modifier) | Time varying covariate for total minutes of moderate to vigorous intensity physical activity, assessed by accelerometry. | Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome | |
Other | Sex Hormone-Binding Globulin (SHBG) | Possible future analysis of archived specimen | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Urinary nitrogen | Archived for future analysis | End of residential (END, 10 weeks) | |
Other | Glucagon-like peptide-1 (GLP-1) | Possible future analyses of archived samples | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Glucose-dependent insulinotropic polypeptide (GIP) | Possible future analyses of archived samples | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Glucagon | Possible future analyses of archived samples | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Oxytocin | Possible future analyses of archived samples | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Other | Oxyntomodulin | Possible future analyses of archived samples | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Primary | Body fat mass | Body composition assessed using a multi-component model | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Lean body mass | Assessed using a multi-component model (difference between total body mass and fat mass) | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Body weight | Anthropometrics, assessed by calibrated scale, in kilograms (kg) | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Total energy expenditure (TEE) | Assessed using doubly labeled water methodology | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Resting energy expenditure (REE) | Assessed by indirect calorimetry using respiratory gas exchange methodology with a ventilated hood system | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Physical activity level, (moderate to vigorous) | Total minutes of moderate- to vigorous-intensity physical activity, assessed by accelerometry | Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome | |
Secondary | Insulin sensitivity | Assessed by frequently-sampled oral glucose tolerance test [OGTT], calculated using plasma insulin and glucose values | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Insulin secretion | Assessed by frequently-sampled oral glucose tolerance test [OGTT], using plasma insulin at 30 minutes following the dose of dextrose | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Glycemic control | Hemoglobin A1c [HbA1c] | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Total cholesterol | Chronic disease risk factor | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | HDL-cholesterol | Chronic disease risk factor | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | LDL-cholesterol | Chronic disease risk factor | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Non-HDL cholesterol | Chronic disease risk factor | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Triglycerides | Chronic disease risk factor | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Plasminogen Activator Inhibitor-1 [PAI-1] | Indicator of coagulopathy | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | High-sensitivity C-reactive protein [hsCRP] | Indicator of chronic inflammation | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Uric acid | Indicator of risk for kidney stones, measured in blood | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Systolic blood pressure | Assessed by auscultation, mmHg | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Diastolic blood pressure | Assessed by auscultation, mmHg | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Thyroxine (T4) | Thyroid function | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Free T4 | Thyroid function | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Thyroid stimulating hormone [TSH] | Thyroid function | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Insulin-like growth factor-1 [IGF-1] | Growth hormone action | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Urine cortisol | Stress hormone, assessed using 24-hour urine collection | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Urine catecholamines | Stress hormone, assessed using 24-hour urine collection | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Leptin | Adipokine | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Total Adiponectin | Adipokine | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | High-molecular weight adiponectin | Adipokine | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Sleep | Total sleep time, sleep onset latency, wake after sleep onset, and sleep efficiency, assessed by accelerometry | Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome | |
Secondary | Blood glucose | Assessed by continuous glucose monitoring (CGM) | Measurements made daily during residential phase (0 to 10 weeks) and integrated into a unified outcome | |
Secondary | Ghrelin | Hormonal Control of Appetite | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Body Circumference | Assessed using a 3D body scan | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) | |
Secondary | Post-prandial energy expenditure and respiratory quotient | Optional testing, assessed by indirect calorimetry using respiratory gas exchange | Single assessment in weeks 6 to 8 of residential study | |
Secondary | Activation of insulin signaling pathways | Assessed by immunohistochemistry of phosphorylated insulin receptor and signaling proteins | Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks) |
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