UAB Weight Loss Medicine Clinic
Birmingham, Alabama, 35205, United States
NCT Number: NCT03459703
Time-restricted feeding (TRF) is a novel type of intermittent fasting that involves eating within a daily period of 10 hours or less, followed by fasting for at least 14 hours daily. Several studies in rodents report that TRF reduces body weight, improves blood sugar control, and reduces the risk of cardiovascular disease-even when food intake is matched to the control group or no weight loss occurs. Preliminary evidence suggests that TRF may also increase weight loss, fat loss, and reduce the risk of diabetes and cardiovascular disease in humans. This study will test whether TRF enhances fat loss and increases weight loss in adults with obesity, relative to conventional dieting alone. In addition, this study will determine whether TRF reduces risk factors for type 2 diabetes and cardiovascular disease and will measure the feasibility and acceptability of TRF.
In conjunction with the parent study described above, four ancillary studies will be conducted:
1. Effect of weight loss on nitrogen metabolism and bacteria in the mouth. The primary endpoints for this ancillary study are plasma and salivary nitrate and nitrite, and the secondary endpoints are salivary nitrate reductase activity and salivary bacterial abundance. 2. Effect of weight loss on several biomarkers related to kidney stones. The primary endpoint for this ancillary study is urinary oxalate, and the secondary endpoints are urinary citrate, chloride, sodium, potassium, calcium, phosphorus, uric acid, and creatinine. 3. Effect of meal timing on blood pressure regulation and kidney function. The primary endpoints of this ancillary study include urinary aldosterone excretion, sodium, potassium, and endothelin, whereas the secondary endpoints include nitric oxide and albumin. Additional exploratory endpoints include renal injury markers (KIM-1, nephrin, and urine albumin-to-creatinine ratio), measures of reactive oxidative stress (e.g., hydrogen peroxide and TBARs), and urinary exosomes. Urine will be analyzed in 12-hour bins to determine how meal timing affects differentially affects these endpoints during the daytime and nighttime. The effects of weight loss on these endpoints may also be considered. 4. Validation of a meal timing questionnaire to assess the distribution of food intake throughout the day.
Looking for future studies?
Notify Me25 year–75 year
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35205, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eat all meals between 7 am - 3 pm for an average of ≥6 days per week.
Other names: Early TRF, eTRF
Eat all meals over a 12-hour or longer period for an average of ≥6 days per week.
A structured weight loss program with physical activity recommendations and dietary counseling.
Time frame: 14 weeks
Percent of weight lost as fat, as measured by dual-energy X-ray absorptiometry (DXA). Lean mass retention will be quantified as 100% minus percent of weight lost as fat (i.e., is measured in the same units).
Time frame: 14 weeks
Change in body weight (kg), as measured by scale weight
Time frame: 14 weeks
Changes in total fat mass, lean mass, bone mass, and regional values (kg), as measured by DXA. (This will be secondary to the assessment of fat loss and lean mass retention as specified above.)
Time frame: 14 weeks
Fasting glucose (mg/dl)
Time frame: 14 weeks
Fasting insulin (IU/L)
Time frame: 14 weeks
HbA1c (%)
Time frame: 14 weeks
Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
Time frame: 14 weeks
Systolic and diastolic blood pressure (mm Hg)
Time frame: 14 weeks
Heart rate in beats per minute
Time frame: 14 weeks
Waist circumference (cm)
Time frame: 14 weeks
Hunger and fullness as measured by Likert (1-5 scale) and visual analog scales (a 0-100 scale, with 0 meaning "Not at all" and 100 meaning "Extremely")
Time frame: 14 weeks
Energy intake and food intake in kcal/day, as measured using Remote Food Photography Method (RFPM)
Time frame: 14 weeks
% of calories as fat, carbohydrate, and protein, as measured using RFPM
Time frame: 14 weeks
Number of meals and snacks per day, as measured using RFPM
Time frame: 14 weeks
Clock times of meals and snacks, as measured using RFPM
Time frame: 14 weeks
Start and stop times and mid-points of daily eating in clock time, as assessed by the daily adherence survey
Time frame: 14 weeks
Average duration of the daily eating period (hours), as measured by the daily adherence survey
Time frame: 14 weeks
Distribution of calories eaten across the day in % per time period, as measured by a novel questionnaire that is being validated
Time frame: 14 weeks
Presence and degree of breakfast and nighttime eating, as measured by a novel questionnaire that is being validated
Time frame: 14 weeks
Self-reported adherence rate in days per week
Time frame: 14 weeks
Reasons for non-adherence, as measured by the daily adherence survey
Time frame: 14 weeks
Attrition rate (%)
Time frame: 14 weeks
Depression as measured by the Patient Health Questionnaire-9. (Each question is scored on a 0-3 scale, where 0 means "Not at all" and 3 means "Nearly every day." Answers to each question are tallied to create a single composite score of depression from 0-27, with higher values meaning more depressive symptoms.)
Time frame: 14 weeks
Mood states as measured by the Profile of Mood States (a 5-point scale with 1 meaning "Not at all" and 5 meaning "Extremely"). This study is particularly interested in the scores for anxiety and related moods.
Time frame: 14 weeks
Chronotype/mid-point of sleep (in clock time), as measured by the Munich Chronotype Questionnaire
Time frame: 14 weeks
Stimulant usage, as measured by the Munich Chronotype Questionnaire (in "servings" per time)
Time frame: 14 weeks
Sleep duration, as measured by the Pittsburgh Sleep Quality Index
Time frame: 14 weeks
Sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PQSI) (This study will use the Global PQSI score, which ranges from 0-21, where higher values correspond to worse sleep quality.)
Time frame: 14 weeks
Restrained, emotional, and external eating, as measured by the Dutch Eating Behavior Questionnaire. (Individual questions are scored on a 5-point scale ranging from "Never" to "Very often," and composite scores for restrained, emotional, and external eating are tabulated, with higher numbers reflecting more of each trait.)
Time frame: 14 weeks
Loneliness, as measured by the UCLA Loneliness Scale (a 3-point scale with 1 meaning "hardly ever" and 3 meaning "often")
Time frame: 14 weeks
Intervention satisfaction and barriers and facilitators of adherence, as measured by qualitative exit interview
Time frame: 14 weeks
Social life and daily habits, as measured by the frequency of occurrence of social activities (5- and 8-point rating scales)
Time frame: 14 weeks
Physical activity status, as measured by the Baecke Physical Activity questionnaire
Time frame: 14 weeks
Plasma and salivary nitrate and nitrite (nM)
Time frame: 14 weeks
Salivary nitrate reductase activity (nmol / min / colony forming unit) in tongue swab samples
Time frame: 14 weeks
Salivary bacterial abundance (colony forming units) in tongue swab samples
Time frame: 14 weeks
24-hour urinary oxalate, citrate, sodium, calcium, chloride, potassium, and creatinine, as measured in mg/day
Time frame: 14 weeks
24-hour urinary phosphorus and uric acid, as measured in g/day
Time frame: 14 weeks
24-hour urinary aldosterone excretion (µg/12 hr)
Time frame: 14 weeks
12-hour urinary sodium and potassium (mmol/12 hr)
Time frame: 14 weeks
12-hour urinary endothelin (ng/12 hr)
Time frame: 14 weeks
12-hour urinary nitric oxide (mmol/12 hr)
Time frame: 14 weeks
12-hour urinary albumin (mg/12 hr)
Time frame: 14 weeks
12-hour urinary KIM-1 (pg/g creatinine or pg/12 hr)
Time frame: 14 weeks
12-hour urinary nephrin (ng/g creatinine or ng/12 hr)
Time frame: 14 weeks
12-hour albumin-to-creatinine ratio
Time frame: 14 weeks
12-hour urinary hydrogen peroxide and TBARs (µmol/g creatinine or µmol/12 hr)
Time frame: 14 weeks
Urinary exosomes (particles/ml)
University of Alabama at Birmingham
Other
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