NCT03278236: RESHAPE2

Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?

Terminated NA Last updated 25 May 2018

What this trial tests

NA trial testing TRF in Type2 Diabetes in 1 participant. Terminated before completion.

Timeline

21 September 2017

Primary endpoint
1 December 2017

1 December 2017

Quick facts

Lead sponsor	University of Adelaide
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	1
Start date	21 September 2017
Primary completion	1 December 2017
Estimated completion	1 December 2017
Sites	1 location across Australia

Drugs / interventions tested

• TRF

Conditions studied

• Type2 Diabetes — all drugs for Type2 Diabetes →
• Insulin Resistance — all drugs for Insulin Resistance →

Sponsor

University of Adelaide

Who can join

Adults 45 to 70, male only, with Type2 Diabetes or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.