Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT03590158
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2018-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Time RestrIcted Feeding For Improving Diabetes Risk (TRIFFID)
Sponsor:
University of Adelaide
Organization:
Study Overview
Official Title:
The Metabolic Impacts of Time-restricted Feeding in Men at High Risk of Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIFFID
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: