Status:
COMPLETED
Time Restricted Feeding and Metabolic Rhythms
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Diabetes
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief Summary
Current guidelines for the prevention and treatment of obesity focus on caloric restriction diets and increasing physical activity, but long-term compliance to these strategies is poor. The timing of ...
Detailed Description
Time restricted feeding (TRF; eating within \<10-h period followed by \>14-h fast) is a promising meal timing paradigm that in rodent studies improves multiple health indicators. When provided access ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04009239
Start Date
January 15 2019
End Date
April 8 2022
Last Update
July 14 2022
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045