Time Restricted Feeding for Weight Loss and Cardio-protection
1 other identifier
interventional
31
1 country
1
Brief Summary
Time restricted feeding (TRF) is a novel form of intermittent fasting that involves confining the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. TRF is effective for weight loss and cardio-protection in obese adults. It is of great interest to see whether subjects can adhere to TRF for longer periods of time, and to see what degree of weight loss that can be achieved with TRF. Accordingly, the aims of this trial are: Aim 1: To determine if TRF can be implemented to facilitate weight loss in obese adults, and Aim 2: To determine if TRF can produce clinically meaningful reductions in plasma lipids, blood pressure, insulin resistance, and inflammatory markers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 25, 2016
CompletedFirst Posted
Study publicly available on registry
October 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedMay 2, 2018
April 1, 2018
11 months
October 25, 2016
April 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Body weight
12 weeks
Secondary Outcomes (4)
Plasma lipids
12 weeks
Blood pressure
12 weeks
Insulin resistance measured by Homeostatic model assessment (HOMA)
12 weeks
Inflammatory markers: Tumor necrosis factor-alpha (TNF) and Interleukin-6 (IL-6)
12 weeks
Study Arms (2)
Time restricted feeding
EXPERIMENTALTime restricted feeding
Control
NO INTERVENTIONNo intervention
Interventions
Eligibility Criteria
You may qualify if:
- Male or female
- Body mass index (BMI) between 30.0 and 40 kg/m2
- Age between 25 and 65 years
- Sedentary (light exercise less than 1 h per week) or moderately active (moderate exercise 1 to 2 h per week)
- Weight stable for \>3 months prior to the beginning of the study (gain or loss \<4 kg)
- Able to give written informed consent
You may not qualify if:
- Smoker
- Diabetic
- History of cardiovascular disease (myocardial infarction or stroke)
- Taking weight loss medications
- History of eating disorders
- Night-shift workers
- Perimenopausal
- Pregnant or trying to become pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois, Chicago
Chicago, Illinois, 60622, United States
Related Publications (1)
Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PMID: 33512717DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Krista Varady, PhD
University of Illinois Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 25, 2016
First Posted
October 28, 2016
Study Start
September 1, 2016
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
May 2, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share