NCT03278236

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

September 21, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

September 7, 2017

Last Update Submit

May 23, 2018

Conditions

Type2 DiabetesInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Change in glycaemia

    Change in fasting and postprandial blood glucose following a standard meal test

    3 hours

Secondary Outcomes (8)

  • Change in HbA1c

    6 weeks

  • Change in body weight

    6 weeks

  • Change in waist and hip circumference

    6 weeks

  • Change in insulin

    3 hours

  • Change in gut peptides

    3 hours

  • +3 more secondary outcomes

Study Arms (1)

TRF

EXPERIMENTAL
Behavioral: TRF

Interventions

TRFBEHAVIORAL

Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.

TRF

Eligibility Criteria

Age45 Years - 70 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adelaide Medical School

Adelaide, South Australia, 5005, Australia

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Leonie Heilbronn, PhD

    University of Adelaide

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A/Prof

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 11, 2017

Study Start

September 21, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 25, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

Food intake data obtained from the MyCircadianApp will be shared between the researchers and the collaborators.

Shared Documents
ICF

Locations

AU(1)