NCT03590158

Brief Summary

This study will explore the effects of eight weeks of time-restricted feeding (TRF) on body weight and composition, glycaemic control, 24-hour glucose profiles, glucoregulatory hormones, and cardiovascular risk in men at high risk of type 2 diabetes. The investigators hypothesise that 8 weeks of TRF will reduce body weight, improve body composition, improve glycaemic control and blood lipid profiles. The potential mechanism will be explored in terms of the changes in gene expression patterns and multi-omics level (e.g., adipose tissue transcriptome, blood proteome).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

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

July 12, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 17, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

12 months

First QC Date

July 12, 2018

Last Update Submit

July 28, 2019

Conditions

Type2 DiabetesObesity

Outcome Measures

Primary Outcomes (1)

  • Glycaemia

    Change in postprandial glucose (iAUC) following a standard breakfast

    2.5 hours

Secondary Outcomes (18)

  • Insulin

    2.5 hours

  • HbA1c

    8 weeks

  • Body weight

    8 weeks

  • Body composition

    8 weeks

  • Waist and hip circumference

    8 weeks

  • +13 more secondary outcomes

Other Outcomes (4)

  • Hair follicle clock gene expression

    8 weeks

  • Resting metabolic rate

    8 weeks

  • Metagenomics and metabolomics

    8 weeks

  • +1 more other outcomes

Study Arms (1)

TRF

EXPERIMENTAL

Participants will follow their regular diet for two weeks before 3-day lead-in food prior to the metabolic testing at visit 0. Participants will then be instructed to eat their habitual diet only within a 10-hour time frame each day for 8 weeks. Participants may self-select the precise window that best suits their lifestyles, however any food and drink must be consumed by 7:30pm.

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

Age40 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Waist circumference ≥94 cm
  • Weight-stable (\< 5 % fluctuation in their body weight for past 6-months at study entry)

You may not qualify if:

  • Personal history and/or diagnosis of: diabetes, cancer, major psychiatric disorders, liver disease, gastro-intestinal surgery or disease (including malabsorption), eating disorders, anaemia, insomnia, cardiovascular disease deemed unstable by the study physician.
  • use of prescribed or non-prescribed medications which may affect energy metabolism, gastrointestinal function, body weight or appetite, sleep (e.g: domperidone and cisapride, anticholinergic drugs (e.g.: atropine), metoclopramide, orlistat, thyroid medications, diuretics, glucocorticoids, sex steroids, metformin, dipeptidyl peptidase-IV inhibitors, melatonin)
  • recent weight change in past 3 months (\> 5% current body weight)
  • individuals who regularly perform high intensity exercise (\>2 week)
  • current intake of \> 140g alcohol/week
  • current smokers of cigarettes/cigars/marijuana/e-cigarettes/vaporisers
  • current intake of any illicit substance
  • unable to comprehend study protocol
  • currently performing shift work
  • has undertaken, or is planning to undertake, trans meridian travel during the study period, or the preceding 60 days
  • do not own a smartphone
  • eats for less than a 12-hour period per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Adelaide

Adelaide, South Australia, Australia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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

July 12, 2018

First Posted

July 18, 2018

Study Start

July 17, 2018

Primary Completion

June 29, 2019

Study Completion

June 29, 2019

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)