Clinical trial NCT03590158: Time RestrIcted Feeding For Improving Diabetes Risk (TRIFFID)
Official title: The Metabolic Impacts of Time-restricted Feeding in Men at High Risk of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Obesity
Lead sponsor: University of Adelaide
Sponsor class: OTHER
Collaborators: name: University of South Australia
name: Salk Institute for Biological Studies
First posted: 2018-07-18
Enrollment: 15
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Glycaemia
timeFrame: 2.5 hours
Secondary outcomes:
measure: Insulin
timeFrame: 2.5 hours
measure: HbA1c
timeFrame: 8 weeks
measure: Body weight
timeFrame: 8 weeks
measure: Body composition
timeFrame: 8 weeks
measure: Waist and hip circumference
timeFrame: 8 weeks
measure: 24-hour glucose profile
timeFrame: 8 weeks
measure: Blood pressure
timeFrame: 8 weeks
measure: Blood lipids
timeFrame: 8 weeks
measure: Non-esterified fatty acid (NEFA)
timeFrame: 8 weeks
measure: Plasma gastrointestinal (GI) hormones
timeFrame: 8 weeks
measure: Plasma cortisol
timeFrame: 8 weeks
measure: Plasma Melatonin
timeFrame: 8 weeks
measure: Adipose tissue transcriptome
timeFrame: 8 weeks
measure: Evening glycaemia
timeFrame: 8 weeks
measure: Physical activity and sleep
timeFrame: 8 weeks
measure: Food intake and meal timing
timeFrame: 8 weeks
measure: Continuous glucose monitoring
timeFrame: 8 weeks
measure: Objective sleep
timeFrame: 8 weeks
Other outcomes:
measure: Hair follicle clock gene expression
timeFrame: 8 weeks
measure: Resting metabolic rate
timeFrame: 8 weeks
measure: Metagenomics and metabolomics
timeFrame: 8 weeks
measure: Plasma proteome
timeFrame: 8 weeks
Locations:
city: Adelaide
country: Australia
facility: University of Adelaide
state: South Australia
Study officials:
affiliation: University of Adelaide
name: Leonie Heilbronn, PhD
role: PRINCIPAL_INVESTIGATOR
References: