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Time RestrIcted Feeding For Improving Diabetes Risk (TRIFFID) (TRIFFID)

Primary Purpose

Type2 Diabetes, Obesity

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
TRF
Sponsored by
University of Adelaide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type2 Diabetes

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Adelaide

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TRF

Arm Description

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.

Outcomes

Primary Outcome Measures

Glycaemia
Change in postprandial glucose (iAUC) following a standard breakfast

Secondary Outcome Measures

Insulin
Change in fasting and postprandial insulin following a standard breakfast.
HbA1c
Change in HbA1c
Body weight
Change in body weight
Body composition
Change in body fat mass and fat free mass
Waist and hip circumference
Change in waist and hip circumference
24-hour glucose profile
Change in 24-hour glucose profiles assessed by continuous glucose monitoring
Blood pressure
Changes in systolic blood pressure and diastolic blood pressure
Blood lipids
changes in blood lipid profile (total cholesterol, HDL-, LDL- cholesterol and triglycerides)
Non-esterified fatty acid (NEFA)
Change in non-essential fatty acid (NEFA)
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.
Plasma cortisol
Changes in concentration of cortisol in hourly plasma samples assessed from 6am to 12pm.
Plasma Melatonin
Changes in dim light melatonin onset (DLMO) assessed from 5pm to 3am
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.
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.
Physical activity and sleep
An ancillary study will measure the changes in sleep and physical activity monitored by a wrist actigraph for 14 days.
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.
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.
Objective sleep
Changes in objective sleep status measured by laboratory polysomnography (PSG).

Full Information

First Posted
July 12, 2018
Last Updated
July 28, 2019
Sponsor
University of Adelaide
Collaborators
University of South Australia, Salk Institute for Biological Studies
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1. Study Identification

Unique Protocol Identification Number
NCT03590158
Brief Title
Time RestrIcted Feeding For Improving Diabetes Risk (TRIFFID)
Acronym
TRIFFID
Official Title
The Metabolic Impacts of Time-restricted Feeding in Men at High Risk of Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
June 29, 2019 (Actual)
Study Completion Date
June 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Adelaide
Collaborators
University of South Australia, Salk Institute for Biological Studies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRF
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TRF
Intervention Description
Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.
Primary Outcome Measure Information:
Title
Glycaemia
Description
Change in postprandial glucose (iAUC) following a standard breakfast
Time Frame
2.5 hours
Secondary Outcome Measure Information:
Title
Insulin
Description
Change in fasting and postprandial insulin following a standard breakfast.
Time Frame
2.5 hours
Title
HbA1c
Description
Change in HbA1c
Time Frame
8 weeks
Title
Body weight
Description
Change in body weight
Time Frame
8 weeks
Title
Body composition
Description
Change in body fat mass and fat free mass
Time Frame
8 weeks
Title
Waist and hip circumference
Description
Change in waist and hip circumference
Time Frame
8 weeks
Title
24-hour glucose profile
Description
Change in 24-hour glucose profiles assessed by continuous glucose monitoring
Time Frame
8 weeks
Title
Blood pressure
Description
Changes in systolic blood pressure and diastolic blood pressure
Time Frame
8 weeks
Title
Blood lipids
Description
changes in blood lipid profile (total cholesterol, HDL-, LDL- cholesterol and triglycerides)
Time Frame
8 weeks
Title
Non-esterified fatty acid (NEFA)
Description
Change in non-essential fatty acid (NEFA)
Time Frame
8 weeks
Title
Plasma gastrointestinal (GI) hormones
Description
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.
Time Frame
8 weeks
Title
Plasma cortisol
Description
Changes in concentration of cortisol in hourly plasma samples assessed from 6am to 12pm.
Time Frame
8 weeks
Title
Plasma Melatonin
Description
Changes in dim light melatonin onset (DLMO) assessed from 5pm to 3am
Time Frame
8 weeks
Title
Adipose tissue transcriptome
Description
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.
Time Frame
8 weeks
Title
Evening glycaemia
Description
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.
Time Frame
8 weeks
Title
Physical activity and sleep
Description
An ancillary study will measure the changes in sleep and physical activity monitored by a wrist actigraph for 14 days.
Time Frame
8 weeks
Title
Food intake and meal timing
Description
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.
Time Frame
8 weeks
Title
Continuous glucose monitoring
Description
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.
Time Frame
8 weeks
Title
Objective sleep
Description
Changes in objective sleep status measured by laboratory polysomnography (PSG).
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Hair follicle clock gene expression
Description
Changes in the circadian pattern of clock gene expression in hair follicles.
Time Frame
8 weeks
Title
Resting metabolic rate
Description
A subset of participants will be examined for the changes in resting metabolic rate and respiratory quotient.
Time Frame
8 weeks
Title
Metagenomics and metabolomics
Description
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.
Time Frame
8 weeks
Title
Plasma proteome
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonie Heilbronn, PhD
Organizational Affiliation
University of Adelaide
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Adelaide
City
Adelaide
State/Province
South Australia
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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Time RestrIcted Feeding For Improving Diabetes Risk (TRIFFID)

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