Daily vs Intermittent Restriction of Energy: Controlled Trial to Reduce Diabetes Risk (DIRECT)
Other study identifiers
Sponsor study identifier
interventional
209
1 country
1
Study Start
September 26, 2018
Actual (reported)Primary Completion
November 30, 2020
Actual (reported)Study Completion
November 30, 2021
Actual (reported)Brief Summary
In this randomized controlled trial, the investigators will compare the long term effectiveness of intermittent fasting (IF) versus an energy matched moderate calorie restriction (CR) over 18 months, and relative to a non-active intervention standard control (SC) in individuals who are at increased risk of developing type 2 diabetes. All participants will be required to attend the blood tests following a 12-hour overnight fast for the "A" visit at Month 0, 2, 6 (active) and 18 (follow up). Fast424hGlucose: A subset of 100 participants enrolled in either IF or CR group in the parent study will be fitted with a continuous glucose monitor (CGM) to measure 24-hour glycaemic profile at month 0 and month 6. Fast4Switch: Additional bloods will be collected after a "B" visit at month 6 to compare the fed to fasted switch. The B samples will be collected after a 12-hour overnight fast (CR, SC) or 20-hour fast (IF) to assess the metabolic switch to fasting in metabolites and hormones. Fast4Stress: Additional subcutaneous adipose tissue, urine and saliva samples will be collected in \~32 men in IF and CR groups at month 0 and 6 at A and B visits to examine changes in stress response and resistance markers. Experience2Fast: In-depth, semi-structured interviews will be carried out at month-8 follow-up visit in a subset of completers from IF or CR groups to explore the experience of intervention diets and understand contributing factors towards change and maintenance of dietary behaviours. Fast4Flux: Additional blood samples will be collected in \~100 individuals in SC, IF and CR groups at month 0, month 2 and month 6 at A visit to measure autophagic flux in peripheral blood mononuclear cells following treatment of whole blood.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 209 participants
- Study completion date
November 30, 2021
Actual (reported)- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
September 26, 2018
Actual (reported)Study Start
September 26, 2018
Actual (reported)First Posted
September 28, 2018
Actual (reported)Primary Completion
November 30, 2020
Actual (reported)Study Completion
November 30, 2021
Actual (reported)
- Last Updated
- January 11, 2022
- Status Verified
- December 2021
- Last Update Submitted
- December 20, 2021