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Completed

NCT Number: NCT03590158

Time RestrIcted Feeding For Improving Diabetes Risk (TRIFFID)

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).

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Key information

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Adelaide

Adelaide, South Australia, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRF

Behavioral

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

Primary outcomes

  1. Glycaemia

    Time frame: 2.5 hours

    Change in postprandial glucose (iAUC) following a standard breakfast

Secondary outcomes

  1. Insulin

    Time frame: 2.5 hours

    Change in fasting and postprandial insulin following a standard breakfast.

  2. HbA1c

    Time frame: 8 weeks

    Change in HbA1c

  3. Body weight

    Time frame: 8 weeks

    Change in body weight

  4. Body composition

    Time frame: 8 weeks

    Change in body fat mass and fat free mass

  5. Waist and hip circumference

    Time frame: 8 weeks

    Change in waist and hip circumference

  6. 24-hour glucose profile

    Time frame: 8 weeks

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

  7. Blood pressure

    Time frame: 8 weeks

    Changes in systolic blood pressure and diastolic blood pressure

  8. Blood lipids

    Time frame: 8 weeks

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

  9. Non-esterified fatty acid (NEFA)

    Time frame: 8 weeks

    Change in non-essential fatty acid (NEFA)

  10. Plasma gastrointestinal (GI) hormones

    Time frame: 8 weeks

    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.

  11. Plasma cortisol

    Time frame: 8 weeks

    Changes in concentration of cortisol in hourly plasma samples assessed from 6am to 12pm.

  12. Plasma Melatonin

    Time frame: 8 weeks

    Changes in dim light melatonin onset (DLMO) assessed from 5pm to 3am

  13. Adipose tissue transcriptome

    Time frame: 8 weeks

    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.

  14. Evening glycaemia

    Time frame: 8 weeks

    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.

  15. Physical activity and sleep

    Time frame: 8 weeks

    An ancillary study will measure the changes in sleep and physical activity monitored by a wrist actigraph for 14 days.

  16. Food intake and meal timing

    Time frame: 8 weeks

    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.

  17. Continuous glucose monitoring

    Time frame: 8 weeks

    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.

  18. Objective sleep

    Time frame: 8 weeks

    Changes in objective sleep status measured by laboratory polysomnography (PSG).

Other outcomes

  1. Hair follicle clock gene expression

    Time frame: 8 weeks

    Changes in the circadian pattern of clock gene expression in hair follicles.

  2. Resting metabolic rate

    Time frame: 8 weeks

    A subset of participants will be examined for the changes in resting metabolic rate and respiratory quotient.

  3. Metagenomics and metabolomics

    Time frame: 8 weeks

    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.

  4. Plasma proteome

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Adelaide

Other

Collaborators

  • Salk Institute for Biological Studies
  • University of South Australia

Registry information

Official study title

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

Acronym: TRIFFID

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 18, 2018
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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