Daily vs Intermittent Restriction of Energy: Controlled Trial to Reduce Diabetes Risk (DIRECT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-26

Study Completion Date

2021-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health

NCT01769976

Insulin Resistance

COMPLETED NA

Intermittent Fasting for Metabolic Health, Does Meal Timing Matter?

NCT02633722

Type 2 Diabetes Insulin Resistance

COMPLETED NA

Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus

NCT05860413

Type 2 Diabetes

COMPLETED NA

Moderately Carbohydrate-restricted Diet to Treat NAFLD in Adolescents

NCT05268042

Non-Alcoholic Fatty Liver Disease Obesity

RECRUITING NA

Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control

NCT06118931

Diabetes Mellitus, Type 2 Obesity Prediabetic State +1 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Individuals at Risk of Developing Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intermittent Fasting (IF)

3 days fasting per week

Group Type EXPERIMENTAL

Intermittent Fasting (IF)

Intervention Type OTHER

Participants will fast 3 days per week. In fasting days, meal replacements at 30% of daily energy requirements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment.

Daily Restriction (DR)

daily energy restriction

Group Type EXPERIMENTAL

Daily Restriction (DR)

Intervention Type OTHER

Participants are instructed to restrict energy intake by 30% of daily energy requirements. Meal replacements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment.

standard care (SC)

usual care

Group Type OTHER

standard care (SC)

Intervention Type OTHER

Participants will receive current practice guidelines in a static information format, will not take part in any counselling or receive meal replacements.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intermittent Fasting (IF)

Participants will fast 3 days per week. In fasting days, meal replacements at 30% of daily energy requirements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment.

Intervention Type OTHER

Daily Restriction (DR)

Participants are instructed to restrict energy intake by 30% of daily energy requirements. Meal replacements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment.

Intervention Type OTHER

standard care (SC)

Participants will receive current practice guidelines in a static information format, will not take part in any counselling or receive meal replacements.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* weight-stable (\< 5 % fluctuation in their body weight for past 6-months at study entry)
* score 12 or greater on the AUSDRISK calculator
* HbA1c \<48 mmol/mol (measured at screening)

Exclusion Criteria

* Personal history/diagnosis (self-reported) of diabetes (type 1 or 2), major psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, eating disorders), gastrointestinal disorders, haematological disorders (i.e. thalassemia, iron-deficiency anaemia) insomnia, or any other medical condition, deemed unstable by the study physician.
* Participants currently taking the following medications will be excluded from participating: any medication used to lower blood glucose or antidiabetic medications (metformin, sulfonylureas, Glucagon-like peptide-1 GLP-1 analogues \[i.e. exenatide\], thiazolidinediones or DPP-IV inhibitors \[i.e. 'gliptins'\]), medications affecting weight, appetite or gut motility (i.e. domperidone, cisapride, orlistat, phentermine, topiramate). Participants who are taking stable doses (i.e. \> 12 months) of androgenic medications (i.e. testosterone) or SSRI's will not be excluded.
* weight change in past 3 months (\> 5% screening weight)
* uncontrolled asthma, current fever, upper respiratory infections
* 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 recreational drugs
* regular blood donor
* unable to comprehend study protocol due to English language or cognitive difficulties

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes