Time RestrIcted Feeding For Improving Diabetes Risk (TRIFFID)

University of Adelaide15 enrolled

Overview

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).

Following a 2 week baseline monitoring phase (food intake by smartphone APP, activity by accelerometer, glucose by continuous glucose monitor), participants will attend the metabolic clinic for testing (visit 0). Body weight, body composition (by DEXA), and blood pressure will be assessed. Blood and adipose tissue samples will be collected over 24-hour period for assessment of glucose, insulin, glucoregulatory hormones, blood lipids and adipose tissue transcriptome. Glucose and insulin responses to a standardised breakfast will be measured. All food will be provided for 3 days prior to the metabolic visit. Following visit 0, participants will be instructed to eat 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 at least 3 hours prior to their usual bedtime. 24-hour glucose profiles, activity and food intake will be measured again at week 6-8. At the end of the 8 weeks, participants will return for a follow-up metabolic visit, identical to that at visit 0, except foods are provided with the 10h time frame.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Type2 Diabetes Obesity

Interventions

TRFBEHAVIORAL

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

Eligibility

Sex: MALEMin age: 40 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Adelaide

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Glycaemia

Change in postprandial glucose (iAUC) following a standard breakfast

Time frame: 2.5 hours

Secondary Outcomes

Insulin

Change in fasting and postprandial insulin following a standard breakfast.

Time frame: 2.5 hours

HbA1c

Change in HbA1c

Time frame: 8 weeks

Body weight

Change in body weight

Time frame: 8 weeks

Body composition

Change in body fat mass and fat free mass

Time frame: 8 weeks

Waist and hip circumference

Change in waist and hip circumference

Time frame: 8 weeks

24-hour glucose profile

Change in 24-hour glucose profiles assessed by continuous glucose monitoring

Time frame: 8 weeks

Blood pressure

Changes in systolic blood pressure and diastolic blood pressure

Time frame: 8 weeks

Blood lipids

changes in blood lipid profile (total cholesterol, HDL-, LDL- cholesterol and triglycerides)

Time frame: 8 weeks

Data from ClinicalTrials.gov

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