An interventional study of Early Time-Restricted Feeding and Control Schedule in Obesity, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-08.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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:
Exclusion Criteria:
Behavioral: Early Time-Restricted Feeding · Behavioral: Structured Weight Loss Program
Behavioral: Control Schedule · Behavioral: Structured Weight Loss Program
Eat all meals between 7 am - 3 pm for an average of ≥6 days per week.
Also known as: 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.
Fat loss and lean mass retention
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
Weight loss
Change in body weight (kg), as measured by scale weight
Time frame: 14 weeks
Absolute changes in body composition
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
Fasting glucose (mg/dl)
Time frame: 14 weeks
Fasting insulin
Fasting insulin (IU/L)
Time frame: 14 weeks
HbA1c
HbA1c (%)
Time frame: 14 weeks
Lipids
Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
Time frame: 14 weeks
Blood pressure
Systolic and diastolic blood pressure (mm Hg)
Time frame: 14 weeks
Heart rate
Heart rate in beats per minute
Time frame: 14 weeks
Waist circumference
Waist circumference (cm)
Time frame: 14 weeks
Appetite
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
Food intake
Energy intake and food intake in kcal/day, as measured using Remote Food Photography Method (RFPM)
Time frame: 14 weeks
Macronutrient intake
% of calories as fat, carbohydrate, and protein, as measured using RFPM
Time frame: 14 weeks
Meal frequency
Number of meals and snacks per day, as measured using RFPM
Time frame: 14 weeks
Meal times
Clock times of meals and snacks, as measured using RFPM
Time frame: 14 weeks
Times of eating
Start and stop times and mid-points of daily eating in clock time, as assessed by the daily adherence survey
Time frame: 14 weeks
Duration of daily eating
Average duration of the daily eating period (hours), as measured by the daily adherence survey
Time frame: 14 weeks
Distribution of food intake across the daytime
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
Breakfast and nighttime eating habits
Presence and degree of breakfast and nighttime eating, as measured by a novel questionnaire that is being validated
Time frame: 14 weeks
Adherence
Self-reported adherence rate in days per week
Time frame: 14 weeks
Reasons for non-adherence
Reasons for non-adherence, as measured by the daily adherence survey
Time frame: 14 weeks
Retention
Attrition rate (%)
Time frame: 14 weeks
Depression
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
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
Chronotype/mid-point of sleep (in clock time), as measured by the Munich Chronotype Questionnaire
Time frame: 14 weeks
Stimulant usage
Stimulant usage, as measured by the Munich Chronotype Questionnaire (in "servings" per time)
Time frame: 14 weeks
Sleep duration
Sleep duration, as measured by the Pittsburgh Sleep Quality Index
Time frame: 14 weeks
Sleep quality
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
Eating Behaviors
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
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
Intervention satisfaction and barriers and facilitators of adherence, as measured by qualitative exit interview
Time frame: 14 weeks
Social life and daily habits
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
Physical activity status, as measured by the Baecke Physical Activity questionnaire
Time frame: 14 weeks
Plasma and salivary nitrate and nitrite
Plasma and salivary nitrate and nitrite (nM)
Time frame: 14 weeks
Salivary nitrate reductase activity
Salivary nitrate reductase activity (nmol / min / colony forming unit) in tongue swab samples
Time frame: 14 weeks
Salivary bacterial abundance
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
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
24-hour urinary phosphorus and uric acid, as measured in g/day
Time frame: 14 weeks
24-hour urinary aldosterone excretion
24-hour urinary aldosterone excretion (µg/12 hr)
Time frame: 14 weeks
12-hour urinary sodium and potassium
12-hour urinary sodium and potassium (mmol/12 hr)
Time frame: 14 weeks
12-hour urinary endothelin
12-hour urinary endothelin (ng/12 hr)
Time frame: 14 weeks
12-hour urinary nitric oxide
12-hour urinary nitric oxide (mmol/12 hr)
Time frame: 14 weeks
12-hour urinary albumin
12-hour urinary albumin (mg/12 hr)
Time frame: 14 weeks
12-hour urinary KIM-1
12-hour urinary KIM-1 (pg/g creatinine or pg/12 hr)
Time frame: 14 weeks
12-hour urinary nephrin
12-hour urinary nephrin (ng/g creatinine or ng/12 hr)
Time frame: 14 weeks
12-hour albumin-to-creatinine ratio
12-hour albumin-to-creatinine ratio
Time frame: 14 weeks
12-hour urinary reactive oxidative stress
12-hour urinary hydrogen peroxide and TBARs (µmol/g creatinine or µmol/12 hr)
Time frame: 14 weeks
Urinary exosomes
Urinary exosomes (particles/ml)
Time frame: 14 weeks
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham