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Completed

NCT Number: NCT03459703

Effect of Time-Restricted Feeding on Fat Loss and Cardiometabolic Risk Factors in Overweight Adults

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.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Weight Loss Medicine Clinic

Birmingham, Alabama, 35205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are a new patient at the UAB Weight Loss Medicine Clinic
  • Aged 25-75 years old
  • BMI between 30-60 kg/m2 (inclusive)
  • Weigh less than 450 lbs
  • Wake up regularly between 4-9 am on most days.

Exclusion criteria

  • Diagnosed with diabetes, have an HbA1c of ≥6.5%, or are on diabetes medication
  • On weight loss medication
  • Addition of or withdrawal from a chronic medication within the past 10 weeks
  • Clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
  • Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
  • Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity
  • Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
  • Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)
  • Lost or gained more than 5 lbs of weight in the past month
  • Currently perform overnight shift work more than once per week on average
  • Regularly eat within a less than 10-hour period each day
  • Regularly eat dinner before 6 pm
  • Traveled more than two time zones away in the two months prior to enrolling in the trial
  • Will travel more than one time zone away during the study
  • Pregnant or breastfeeding

Treatment and study plan

Early Time-Restricted Feeding

Behavioral

Eat all meals between 7 am - 3 pm for an average of ≥6 days per week.

Other names: Early TRF, eTRF

Control Schedule

Behavioral

Eat all meals over a 12-hour or longer period for an average of ≥6 days per week.

Structured Weight Loss Program

Behavioral

A structured weight loss program with physical activity recommendations and dietary counseling.

Primary outcomes

  1. Fat loss and lean mass retention

    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).

  2. Weight loss

    Time frame: 14 weeks

    Change in body weight (kg), as measured by scale weight

  3. Absolute changes in body composition

    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.)

Secondary outcomes

  1. Fasting glucose

    Time frame: 14 weeks

    Fasting glucose (mg/dl)

  2. Fasting insulin

    Time frame: 14 weeks

    Fasting insulin (IU/L)

  3. HbA1c

    Time frame: 14 weeks

    HbA1c (%)

  4. Lipids

    Time frame: 14 weeks

    Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)

  5. Blood pressure

    Time frame: 14 weeks

    Systolic and diastolic blood pressure (mm Hg)

  6. Heart rate

    Time frame: 14 weeks

    Heart rate in beats per minute

  7. Waist circumference

    Time frame: 14 weeks

    Waist circumference (cm)

Other outcomes

  1. Appetite

    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")

  2. Food intake

    Time frame: 14 weeks

    Energy intake and food intake in kcal/day, as measured using Remote Food Photography Method (RFPM)

  3. Macronutrient intake

    Time frame: 14 weeks

    % of calories as fat, carbohydrate, and protein, as measured using RFPM

  4. Meal frequency

    Time frame: 14 weeks

    Number of meals and snacks per day, as measured using RFPM

  5. Meal times

    Time frame: 14 weeks

    Clock times of meals and snacks, as measured using RFPM

  6. Times of eating

    Time frame: 14 weeks

    Start and stop times and mid-points of daily eating in clock time, as assessed by the daily adherence survey

  7. Duration of daily eating

    Time frame: 14 weeks

    Average duration of the daily eating period (hours), as measured by the daily adherence survey

  8. Distribution of food intake across the daytime

    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

  9. Breakfast and nighttime eating habits

    Time frame: 14 weeks

    Presence and degree of breakfast and nighttime eating, as measured by a novel questionnaire that is being validated

  10. Adherence

    Time frame: 14 weeks

    Self-reported adherence rate in days per week

  11. Reasons for non-adherence

    Time frame: 14 weeks

    Reasons for non-adherence, as measured by the daily adherence survey

  12. Retention

    Time frame: 14 weeks

    Attrition rate (%)

  13. Depression

    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.)

  14. Mood states

    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.

  15. Chronotype

    Time frame: 14 weeks

    Chronotype/mid-point of sleep (in clock time), as measured by the Munich Chronotype Questionnaire

  16. Stimulant usage

    Time frame: 14 weeks

    Stimulant usage, as measured by the Munich Chronotype Questionnaire (in "servings" per time)

  17. Sleep duration

    Time frame: 14 weeks

    Sleep duration, as measured by the Pittsburgh Sleep Quality Index

  18. Sleep quality

    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.)

  19. Eating Behaviors

    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.)

  20. Loneliness

    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")

  21. Intervention satisfaction

    Time frame: 14 weeks

    Intervention satisfaction and barriers and facilitators of adherence, as measured by qualitative exit interview

  22. Social life and daily habits

    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)

  23. Physical activity

    Time frame: 14 weeks

    Physical activity status, as measured by the Baecke Physical Activity questionnaire

  24. Plasma and salivary nitrate and nitrite

    Time frame: 14 weeks

    Plasma and salivary nitrate and nitrite (nM)

  25. Salivary nitrate reductase activity

    Time frame: 14 weeks

    Salivary nitrate reductase activity (nmol / min / colony forming unit) in tongue swab samples

  26. Salivary bacterial abundance

    Time frame: 14 weeks

    Salivary bacterial abundance (colony forming units) in tongue swab samples

  27. 24-hour urinary oxalate, citrate, sodium, calcium, chloride, potassium, and creatinine

    Time frame: 14 weeks

    24-hour urinary oxalate, citrate, sodium, calcium, chloride, potassium, and creatinine, as measured in mg/day

  28. 24-hour urinary phosphorus and uric acid

    Time frame: 14 weeks

    24-hour urinary phosphorus and uric acid, as measured in g/day

  29. 24-hour urinary aldosterone excretion

    Time frame: 14 weeks

    24-hour urinary aldosterone excretion (µg/12 hr)

  30. 12-hour urinary sodium and potassium

    Time frame: 14 weeks

    12-hour urinary sodium and potassium (mmol/12 hr)

  31. 12-hour urinary endothelin

    Time frame: 14 weeks

    12-hour urinary endothelin (ng/12 hr)

  32. 12-hour urinary nitric oxide

    Time frame: 14 weeks

    12-hour urinary nitric oxide (mmol/12 hr)

  33. 12-hour urinary albumin

    Time frame: 14 weeks

    12-hour urinary albumin (mg/12 hr)

  34. 12-hour urinary KIM-1

    Time frame: 14 weeks

    12-hour urinary KIM-1 (pg/g creatinine or pg/12 hr)

  35. 12-hour urinary nephrin

    Time frame: 14 weeks

    12-hour urinary nephrin (ng/g creatinine or ng/12 hr)

  36. 12-hour albumin-to-creatinine ratio

    Time frame: 14 weeks

    12-hour albumin-to-creatinine ratio

  37. 12-hour urinary reactive oxidative stress

    Time frame: 14 weeks

    12-hour urinary hydrogen peroxide and TBARs (µmol/g creatinine or µmol/12 hr)

  38. Urinary exosomes

    Time frame: 14 weeks

    Urinary exosomes (particles/ml)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2018
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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