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Intermittent Fasting for Metabolic Health, Does Meal Timing Matter?

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ClinicalTrials.gov Identifier: NCT02633722
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
A/Prof Leonie Heilbronn, University of Adelaide

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Insulin Resistance Behavioral: Lifestyle intervention B Behavioral: Lifestyle Intervention D Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intermittent Fasting for Metabolic Health, Does Meal Timing Matter?
Study Start Date : January 2016
Actual Primary Completion Date : October 30, 2016
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TRF-b
Participants are instructed to eat between 8am-5pm
Behavioral: Lifestyle intervention B
Time limiting feeding from 8-5pm (TRFb)

Experimental: TRF-d
Participants are instructed to eat only between 12-9pm
Behavioral: Lifestyle Intervention D
Time limiting feeding (12-9pm)

No Intervention: Baseline
No lifestyle instruction given



Primary Outcome Measures :
  1. Postprandial glucose response to meal test [ Time Frame: 3-hours ]

Secondary Outcome Measures :
  1. Postprandial insulin response to test meal [ Time Frame: 3 hours ]
  2. Post-prandial gut hormone response to test meal [ Time Frame: 3 hours ]
  3. Glycaemic response over 1 week by continuous glucose monitoring [ Time Frame: 1-week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Waist circumference >102cm
  • BMI >30 kg/m2

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633722


Locations
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Australia, South Australia
University of Adelaide
Adelaide, South Australia, Australia
Sponsors and Collaborators
University of Adelaide
Investigators
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Principal Investigator: Leonie Heilbronn, PhD The University of Adelaide
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: A/Prof Leonie Heilbronn, A/Prof, University of Adelaide
ClinicalTrials.gov Identifier: NCT02633722    
Other Study ID Numbers: UAdelaide
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases