Time Restricted Feeding and Metabolic Rhythms

Plain-language summary

This study looks at the effects of time restricted feeding on metabolic rhythms. Adults aged 20-50 with overweight and class I obesity and a low physical activity level could take part. It was carried out as a study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

University of Colorado, Denver

Intervention

Time Restricted Feeding

Start date

1/15/2019

Estimated completion

4/8/2022

Countries

United States

Related genes

Locations

• Aurora, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Men and women with overweight and class I obesity (N=12, Age=20-50 years; BMI 25-35 kg/m2)
* Low physical activity level (≤150 min/wk of moderate-to-vigorous activity);
* For Females- Not currently pregnant or lactating and not pregnant within the past 6 months
* Habitually consume food over a window of \>12 h/day;
* Pass a medical and physical screening performed by the study physician.
* Report a habitual, regular sleep-wake cycle for the month preceding screening that involved going to bed between 2200 and 0100h and getting up between 0600 and 0900 h with \>7 h and \<9.25 h in bed;
* Agree to eat control diets at imposed times for 1 week prior to the inpatient CTRC visits;
* Agree to keep a regular sleep/wake schedule for the duration of the study
* Possess a smart phone to install and utilize the meal timing application.

Exclusion Criteria:

* Subjects must not be currently participating in another research study that would influence their safe participation in this study. For example, subjects must not be participating in a research study in which they ingest experimental medication, or which involves blood samples, since both of these factors could increase risk of participation;
* Being considered unsafe to participate as determined by the study physician;
* Taking medications affecting weight, triglycerides, energy intake/energy expenditure, or sleep in the last 3 months;
* Having abnormal blood chemistry and/or hematology as deemed significant by the study physician;

  o Have one or more of the following out-of-range values measured on a fasting blood sample: glucose \> 126 mg/dl, HbA1c \> 6.5%, thyroid stimulating hormone \<0.5 or \>5.0 uU/ml. Subjects who may be anemic (hemoglobin \<14.5 g/dl men, \<12.3 g/dl women), have abnormal liver function tests (alanine amino transferase \> 47 U/l, aspartate aminotransferase, \> 47 U/l, alkaline phosphatase \<39 or \>117 U/l) or creatinine (\>1.1 mg/dl)
* Significant abnormality in clinical laboratory values
* Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse;
* History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism;
* Score \> 18 on Beck Depression Index (BDI) will require further assessment by the study physician to determine if it is appropriate for the subject to participate in the study;
* Use of a continuous positive airway pressure (CPAP) device for the treatment of obstructive sleep apnea (OSA). A score of \>10 on the Epworth sleepiness scale or \>5 on the Pittsburgh Sleep Quality Index will require further assessment by the study physician to determine if it is appropriate for the subject to participate in the study;
* Being positive for human immunodeficiency virus or hepatitis B or C;
* Being a smoker or having been a smoker in the previous 6 months;
* Abnormal eating patterns identified by registered dietician interview (dietary fat\<15%, dietary fat\>45%, dietary protein \>30%);
* Working night shifts;
* Night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week);
* Traveling \> 2 time zones 2 weeks prior to an inpatient CTRC study visit;
* Currently participating in any formal weight loss or physical activity programs or clinical trials.
* Having a clinically significant allergy (e.g., to food stuffs such as shellfish, peanuts);
* Celiac disease or known sensitivity to gluten (the metabolic kitchen is not gluten free certified and cannot accommodate this dietary restriction)