Time RestrIcted Feeding For Improving Diabetes Risk (TRIFFID)

Obesity Clinical Trial

— TRIFFID  

Official title:

The Metabolic Impacts of Time-restricted Feeding in Men at High Risk of Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590158
• Other study ID #: R20180320
• Status: Completed
• Phase: N/A
• Start date: July 17, 2018
• Est. completion date: June 29, 2019

Study information

• Verified date: July 2019
• Source: University of Adelaide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 29, 2019
• Est. primary completion date: June 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Australia	University of Adelaide	Adelaide	South Australia

Sponsors (3)

Lead Sponsor	Collaborator
University of Adelaide	Salk Institute for Biological Studies, University of South Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hair follicle clock gene expression	Changes in the circadian pattern of clock gene expression in hair follicles.	8 weeks
Other	Resting metabolic rate	A subset of participants will be examined for the changes in resting metabolic rate and respiratory quotient.	8 weeks
Other	Metagenomics and metabolomics	Changes in metagenome and metabolome in a subset of participants will be assessed in faeces by shotgun metagenomics sequencing and metabolites analysis. The data analysis including but not limited to the function and composition of the gut microbiota, and faecal bile acids.	8 weeks
Other	Plasma proteome	Plasma proteome will be assessed by mass-spectrometry driven analysis. The data analysis including but not limited to the changes in numbers of proteins oscillated in a diurnal manner, and pathway analysis.	8 weeks
Primary	Glycaemia	Change in postprandial glucose (iAUC) following a standard breakfast	2.5 hours
Secondary	Insulin	Change in fasting and postprandial insulin following a standard breakfast.	2.5 hours
Secondary	HbA1c	Change in HbA1c	8 weeks
Secondary	Body weight	Change in body weight	8 weeks
Secondary	Body composition	Change in body fat mass and fat free mass	8 weeks
Secondary	Waist and hip circumference	Change in waist and hip circumference	8 weeks
Secondary	24-hour glucose profile	Change in 24-hour glucose profiles assessed by continuous glucose monitoring	8 weeks
Secondary	Blood pressure	Changes in systolic blood pressure and diastolic blood pressure	8 weeks
Secondary	Blood lipids	changes in blood lipid profile (total cholesterol, HDL-, LDL- cholesterol and triglycerides)	8 weeks
Secondary	Non-esterified fatty acid (NEFA)	Change in non-essential fatty acid (NEFA)	8 weeks
Secondary	Plasma gastrointestinal (GI) hormones	Changes in concentration of fasting and postprandial GI hormones in plasma (ghrelin, glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide, peptide YY) following a standard breakfast.	8 weeks
Secondary	Plasma cortisol	Changes in concentration of cortisol in hourly plasma samples assessed from 6am to 12pm.	8 weeks
Secondary	Plasma Melatonin	Changes in dim light melatonin onset (DLMO) assessed from 5pm to 3am	8 weeks
Secondary	Adipose tissue transcriptome	A subset will be measured for the change in the adipose tissue transcriptome in 6-hourly samples by RNA-sequencing. The data analysis including but not limited to the changes in numbers of genes oscillated in a diurnal manner, and pathway analysis.	8 weeks
Secondary	Evening glycaemia	An ancillary study will be performed to measure the changes in the concentration of plasma glucose, insulin and GI hormones (ghrelin, glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide, peptide YY) following a standard evening meal.	8 weeks
Secondary	Physical activity and sleep	An ancillary study will measure the changes in sleep and physical activity monitored by a wrist actigraph for 14 days.	8 weeks
Secondary	Food intake and meal timing	An ancillary study will measure the changes in food intake and meal timing as recorded via a photography based smartphone App over 2 weeks. The analysis of the App data including but not limited to eating duration at baseline, changes in eating duration after intervention, calorie distribution throughout the day, meal frequency, meal intervals, and macronutrients intake.	8 weeks
Secondary	Continuous glucose monitoring	An ancillary study will measure the changes in glucose level by CGM for 14 days. Daily glucose patterns including free habitual diet, 3-day lead-in food will be measured separately. The analysis of the CGM data including but not limited to assess the mean amplitude of glycaemic excursions (MAGE), continuous overall net glycaemic action (CONGA), mean glucose concentrations.	8 weeks
Secondary	Objective sleep	Changes in objective sleep status measured by laboratory polysomnography (PSG).	8 weeks