N/A
N=164
Framingham State Food Study
Obesity · Diabetes · Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT02068885 ↗Enrolled (actual)
164
Serious AEs
0.5%
Results posted
Nov 2020
Primary outcome: Primary: Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes — 2713; 2504; 2640; 190 kcal/d
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Feeding study (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes |
2713; 2504; 2640; 190; 71; -19 | — |
| SECONDARY Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange |
1615; 1576; 1603; 54; 46; 34 | — |
| SECONDARY Physical Activity, Assessed by Accelerometry |
495.8; 463.8; 476.6; -6.9; -42.4; -26.3 | — |
| SECONDARY Skeletal Muscle Work Efficiency |
12.2; 11.7; 12.2; 0.3; -0.0; -0.1 | — |
| SECONDARY Leptin (Start of Trial) |
9.6; 9.8; 10.9 | — |
| SECONDARY Leptin (% Change) |
17.9; 34.8; 34.2 | — |
| SECONDARY Ghrelin (Start of Trial) |
598.2; 640.1; 693.2 | — |
| SECONDARY Ghrelin (% Change) |
-11.8; -8.7; -4.9 | — |
| SECONDARY 1,5-Anhydroglucitol |
16.7; 17.2; 17.1; -2.5; -1.2; 0.1 | — |
| SECONDARY Glycemic Control, Assessed by HgA1c |
5.56; 5.58; 5.61; 0.01; 0.03; -0.01 | — |
| SECONDARY Triglycerides |
77.3; 76.5; 80.5; -12.1; 8.4; 10.9 | — |
| SECONDARY Body Composition (DXA) |
36.2; 37.3; 37.8; -0.3; -0.3; -0.5 | — |
| SECONDARY Glucose |
95.1; 94.3; 95.1; 1.0; -0.3; -1.0 | — |
| SECONDARY Change in Lipoprotein Particle Subfraction Distribution |
34.6; 31.5; 31.4; -5.3; -0.02; 3.6 | — |
| SECONDARY Total Cholesterol |
147.5; 145.5; 142.9; 16.1; 18.5; 16.2 | — |
| SECONDARY HDL-Cholesterol |
47.8; 49.1; 47.6; 11.1; 6.9; 4.7 | — |
| SECONDARY Non-HDL-Cholesterol |
101.5; 99.0; 98.2; 6.3; 11.0; 9.5 | — |
| SECONDARY LDL-Cholesterol |
80.6; 77.6; 79.5; 10.0; 11.7; 8.2 | — |
| SECONDARY Adiponectin (Start of Trial) |
4.0; 5.1; 4.9; 2.3; 2.8; 2.7 | — |
| SECONDARY Adiponectin (% Change) |
33.6; 17.4; 23.0; 42.9; 27.6; 27.8 | — |
| SECONDARY C-reactive Protein (Start of Trial) |
1.1; 1.5; 1.5 | — |
| SECONDARY C-reactive Protein (% Change) |
-9.9; -20.6; -1.7 | — |
| SECONDARY IL-6 (Start of Trial) |
1.4; 1.8; 1.7 | — |
| SECONDARY IL-6 (% Change) |
-23.6; -20.1; -18.3 | — |
| SECONDARY Blood Pressure |
117.2; 119.2; 114.3; -1.5; 0.0; 1.8 | — |
| SECONDARY Plasminogen Activator Inhibitor-1 (Start of Trial) |
1.1; 1.5; 1.2 | — |
| SECONDARY Plasminogen Activator Inhibitor-1 (% Change) |
7.2; 26.9; 14.9 | — |
| SECONDARY Fibrinogen |
421.1; 461.0; 428.1; -17.0; -22.4; -21.7 | — |
| SECONDARY Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) |
131.4; 116.7; 99.2; 95.9; 79.9; 68.0 | — |
| SECONDARY Thyroxine (T4) |
85; 86; 90; 84; 85; 86 | — |
| SECONDARY Free T4 |
14.3; 15.0; 14.8; 14.9; 15.2; 15.0 | — |
| SECONDARY Thyroid Stimulating Hormone |
2.0; 1.8; 2.1; 2.1; 2.2; 2.5 | — |
| SECONDARY Reverse T3 |
1499; 1548; 1536; 1545; 1554; 1548 | — |
| SECONDARY Urinary Cortisol Excretion |
61; 59; 63; 66; 64; 63 | — |
| SECONDARY Urinary Catecholamine - Adrenaline |
3.1; 3.0; 2.9; 3.5; 3.2; 3.0 | — |
| SECONDARY Urinary Catecholamine - Dopamine |
142.0; 143.2; 117.8; 112.9; 112.4; 104.7 | — |
| SECONDARY Urinary Catecholamine - Noradrenaline |
25.8; 23.9; 25.3; 25.2; 25.3; 24.7 | — |
| SECONDARY Insulin Sensitivity (Hepatic), Assessed by Frequently-sampled Oral Glucose Tolerance Test |
— | — |
| SECONDARY Insulin Sensitivity (Systemic), Assessed by Frequently-sampled Oral Glucose Tolerance Test |
— | — |
| SECONDARY Non-esterified Fatty Acids |
— | — |
| SECONDARY Serum Ketones/Ketoacids |
— | — |
| SECONDARY Lactate |
— | — |
| SECONDARY Metabolic Fuel Concentration in Serum (Glucose, Nonesterified Fatty Acids, Ketones/Ketoacids, Lactate) |
— | — |
| SECONDARY Insulin-like Growth Factor 1 (IGF-1) |
— | — |
| SECONDARY IGF Binding Proteins |
— | — |
| SECONDARY Testosterone |
— | — |
| SECONDARY Estradiol |
— | — |
| SECONDARY Luteinizing Hormone |
— | — |
| SECONDARY Follicle Stimulating Hormone |
— | — |
| SECONDARY Body Weight Change During ad Libitum Feeding |
— | — |
| SECONDARY Gut Microbiome Profile |
— | — |
| SECONDARY Serum Metabolomics Profile |
— | — |
| SECONDARY Change in Cognitive Function Related to Memory |
— | — |
| SECONDARY Change in Cognitive Function Related to Processing Speed and Executive Function |
— | — |
| SECONDARY Change in Self-reported Sleep Quality |
— | — |
| SECONDARY Change in Self-reported Depression Measure |
— | — |
| SECONDARY Change in Self-reported Mood/Anxiety |
— | — |
| SECONDARY Change in Self-reported Food Addiction Score |
— | — |
| SECONDARY Change in Self-reported Emotional Eating Score |
— | — |
| SECONDARY Change in Self-reported Binge Eating Score |
— | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT02068885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.