Intermittent Fasting for Metabolic Health, Does Meal Timing Matter?
1 other identifier
interventional
15
1 country
1
Brief Summary
Obesity is a serious medical condition, the adverse consequences of which include increased risk of cardiovascular disease, diabetes mellitus, reduced fertility and cancer. The economic cost of obesity was placed at $58 billion dollars in Australia in 2008. Studies in mice and non-human primates have shown that moderate caloric restriction (CR) increases lifespan and reduces the incidence of cardiovascular disease, cancer, and type 2 diabetes. Reduced risk of chronic diseases is also observed in humans following CR. However, daily CR is difficult to maintain long term, since the body defends against weight loss by inducing "metabolic adaptation" and altering the hormonal appetite response. An emerging number of studies are examining the effects of limiting food intake to prescribed time periods per day, or every other day. Intermittent, or time restricted feeding describes a dieting approach where food is available ad libitum, however only for a limited period of time (i.e. 3-12 hours). This study will examine the effects of fasting for 15h/day and eating for 9-h per day on glycemic control and metabolic health. This study will build on the existing knowledge base in humans as to whether meal timing, rather than caloric restriction per se, is important to provide the stimulus required to improve metabolic health and reduce risk of chronic disease. Moreover, it will examine whether restricting feeding to later in the day is of lesser benefit to health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started Jan 2016
Typical duration for not_applicable type-2-diabetes
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
First Submitted
Initial submission to the registry
December 15, 2015
CompletedFirst Posted
Study publicly available on registry
December 17, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2018
CompletedOctober 11, 2018
October 1, 2018
10 months
December 15, 2015
October 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Postprandial glucose response to meal test
3-hours
Secondary Outcomes (3)
Postprandial insulin response to test meal
3 hours
Post-prandial gut hormone response to test meal
3 hours
Glycaemic response over 1 week by continuous glucose monitoring
1-week
Study Arms (3)
TRF-b
EXPERIMENTALParticipants are instructed to eat between 8am-5pm
TRF-d
EXPERIMENTALParticipants are instructed to eat only between 12-9pm
Baseline
NO INTERVENTIONNo lifestyle instruction given
Interventions
Eligibility Criteria
You may qualify if:
- Waist circumference \>102cm
- BMI \>30 kg/m2
You may not qualify if:
- Personal history of cardiovascular disease, diabetes, eating disorders
- use of medications which may affect energy metabolism, gastrointestinal function, body weight or appetite (e.g. domperidone and cisapride, anticholinergic drugs, androgenic medications, metoclopramide, orlistat, diuretic medications
- use of prescribed glucose-lowering/antidiabetic medication
- recent weight change in past 3 months,or does not habitually eat breakfast
- uncontrolled asthma, current fever, upper respiratory infections
- current intake of \> 140g alcohol/week
- current smokers of cigarettes/cigars/marijuana
- current intake of any illicit substance
- experience claustrophobia in confined spaces
- has donated blood within past 3-months
- unable to comprehend study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Adelaide
Adelaide, South Australia, Australia
Related Publications (2)
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: 33512717DERIVEDHutchison AT, Regmi P, Manoogian ENC, Fleischer JG, Wittert GA, Panda S, Heilbronn LK. Time-Restricted Feeding Improves Glucose Tolerance in Men at Risk for Type 2 Diabetes: A Randomized Crossover Trial. Obesity (Silver Spring). 2019 May;27(5):724-732. doi: 10.1002/oby.22449. Epub 2019 Apr 19.
PMID: 31002478DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leonie Heilbronn, PhD
The University of Adelaide
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- A/Prof
Study Record Dates
First Submitted
December 15, 2015
First Posted
December 17, 2015
Study Start
January 1, 2016
Primary Completion
October 30, 2016
Study Completion
July 30, 2018
Last Updated
October 11, 2018
Record last verified: 2018-10