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Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men? (RESHAPE2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278236
Recruitment Status : Terminated (Insufficient funding to complete pilot.)
First Posted : September 11, 2017
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
Salk Institute for Biological Studies
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 [1]. 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 [2]. Reduced risk of chronic diseases is also observed in humans following CR [3]. However, daily CR is difficult to maintain long term, since the body defends against weight loss by inducing "metabolic adaptation"[3] and altering the hormonal appetite response [4]. An emerging number of studies are examining the effects of limiting food intake to prescribed time periods per day, or every other day. Time restricted feeding (TRF) describes a dieting approach where food is available ad libitum, however only for a limited period of time (i.e. 3-12 hours).

This pilot study will examine the effects of restricting daily food intake to within a 10 hour period on glycaemic control, body weight and biomarkers of metabolic health for 6-weeks. 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.


Condition or disease Intervention/treatment Phase
Type2 Diabetes Insulin Resistance Behavioral: TRF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?
Actual Study Start Date : September 21, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TRF Behavioral: TRF
Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.




Primary Outcome Measures :
  1. Change in glycaemia [ Time Frame: 3 hours ]
    Change in fasting and postprandial blood glucose following a standard meal test


Secondary Outcome Measures :
  1. Change in HbA1c [ Time Frame: 6 weeks ]
  2. Change in body weight [ Time Frame: 6 weeks ]
    changes in body weight (kg)

  3. Change in waist and hip circumference [ Time Frame: 6 weeks ]
    changes in waist and hip circumference (cm) and waist:hip ratio

  4. Change in insulin [ Time Frame: 3 hours ]
    changes in fasting insulin and insulin response to a standard meal

  5. Change in gut peptides [ Time Frame: 3 hours ]
    changes in fasting gut peptides and gut peptide responses to a standard meal

  6. Change in cardiovascular risk [ Time Frame: 6 weeks ]
    changes in blood pressure, blood lipids after 6 weeks of intervention

  7. Change in appetite [ Time Frame: 3 hours ]
    changes in measures of appetite in response to a standard meal

  8. Change in food intake [ Time Frame: 6 weeks ]
    Change in quantity and nutritional composition of food intake



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

overweight (BMI >25.0 kg/m2) Waist circumference >102 cm

Exclusion Criteria:

  • Personal history of cardiovascular disease, diabetes, major psychiatric disorders, insomnia
  • use of prescribed or non-prescribed medications which may affect energy metabolism, gastrointestinal function, weight or appetite (e.g. domperidone and cisapride, anticholinergic drugs (e.g. atropine), androgenic medications (e.g. testosterone), metoclopramide, orlistat, diuretics)
  • use of prescribed glucose-lowering/antidiabetic medication (e.g. metformin, DPP4 inhibitors)
  • recent weight change in past 3 months, and/or does not habitually eat breakfast
  • uncontrolled asthma, current fever, upper respiratory infections
  • individuals who regularly perform high intensity exercise (>2 week)
  • current intake of > 140g alcohol/week
  • current smokers of cigarettes/cigars/marijuana
  • current intake of any illicit substance
  • current shift worker
  • has donated blood within past 3-months
  • unable to comprehend study protocol
  • does not own a smartphone

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): NCT03278236


Locations
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Australia, South Australia
Adelaide Medical School
Adelaide, South Australia, Australia, 5005
Sponsors and Collaborators
University of Adelaide
Salk Institute for Biological Studies
Investigators
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Principal Investigator: Leonie Heilbronn, PhD University of Adelaide
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Responsible Party: A/Prof Leonie Heilbronn, A/Prof, University of Adelaide
ClinicalTrials.gov Identifier: NCT03278236    
Other Study ID Numbers: HREC/17/RAH/307
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Food intake data obtained from the MyCircadianApp will be shared between the researchers and the collaborators.
Supporting Materials: Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases