University of Adelaide
Adelaide, South Australia, Australia
NCT Number: NCT03590158
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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Notify Me40 year–70 year
Male
Interventional
Not applicable
Adelaide, South Australia, Australia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.
Time frame: 2.5 hours
Change in postprandial glucose (iAUC) following a standard breakfast
Time frame: 2.5 hours
Change in fasting and postprandial insulin following a standard breakfast.
Time frame: 8 weeks
Change in HbA1c
Time frame: 8 weeks
Change in body weight
Time frame: 8 weeks
Change in body fat mass and fat free mass
Time frame: 8 weeks
Change in waist and hip circumference
Time frame: 8 weeks
Change in 24-hour glucose profiles assessed by continuous glucose monitoring
Time frame: 8 weeks
Changes in systolic blood pressure and diastolic blood pressure
Time frame: 8 weeks
changes in blood lipid profile (total cholesterol, HDL-, LDL- cholesterol and triglycerides)
Time frame: 8 weeks
Change in non-essential fatty acid (NEFA)
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.
Time frame: 8 weeks
Changes in concentration of cortisol in hourly plasma samples assessed from 6am to 12pm.
Time frame: 8 weeks
Changes in dim light melatonin onset (DLMO) assessed from 5pm to 3am
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.
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.
Time frame: 8 weeks
An ancillary study will measure the changes in sleep and physical activity monitored by a wrist actigraph for 14 days.
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.
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.
Time frame: 8 weeks
Changes in objective sleep status measured by laboratory polysomnography (PSG).
Time frame: 8 weeks
Changes in the circadian pattern of clock gene expression in hair follicles.
Time frame: 8 weeks
A subset of participants will be examined for the changes in resting metabolic rate and respiratory quotient.
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.
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.
University of Adelaide
Other
The Metabolic Impacts of Time-restricted Feeding in Men at High Risk of Type 2 Diabetes
Acronym: TRIFFID
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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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