Time RestrIcted Feeding For Improving Diabetes Risk (TRIFFID)

NCT ID: NCT03590158

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2019-06-29

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).

Detailed Description

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.

Conditions

Type2 Diabetes; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

TRF

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.

Group Type: EXPERIMENTAL

TRF

Intervention Type: BEHAVIORAL

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

Interventions

TRF

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Australia

OTHER

Sponsor Role: collaborator

Salk Institute for Biological Studies

OTHER

Sponsor Role: collaborator

University of Adelaide

OTHER

Sponsor Role: lead

Responsible Party

A/Prof Leonie Heilbronn

A/Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leonie Heilbronn, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Adelaide

Locations

University of Adelaide

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

R20180320

Identifier Type: -

Identifier Source: org_study_id