Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000479303
Ethics application status
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Approved
Date submitted
Help: Date submitted
21/02/2026
Date registered
Help: Date registered
17/04/2026
Date last updated
Help: Date last updated
17/04/2026
Date data sharing statement initially provided
Help: Data sharing statement date
17/04/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
A study of time-restricted eating and the risk of Alzheimer’s dementia.
Scientific title
Time-restricted eating Alzheimer's Trial (TREAT): A randomized controlled feasibility trial in participants with a family history of Alzheimer's dementia.
Additional trial identifiers [1] 316598 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Alzheimer's dementia 340785 0
Condition category
Condition code
Neurological 336961 336961 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is intermittent fasting through time-restricted eating (TRE). It is defined as a longer than usual intervals between caloric meals. For this study 15 hours fasting five days a week will be investigated. During fasting participants will not consume any food that contains calory. Non-caloric items, such as water, black coffee or tea without sugar, and sparkling water are allowed.
A dementia specialist doctor will educate participants about the intervention. The education session will involve one hour face to face session focusing on the health benefits and practical aspects of intermittent fasting. For example, the education session will inform participants that hunger pains are normal physiological reactions to empty stomach and they can be addressed by consuming a glass of water. The education will also cover common side effects of fasting such as, tiredness, irritability, and loss of lean body mass.
The Occupational Therapist will provide the fasting diary and education about how to report fasting and exercise hours. The study team will consult participants' general practitioners to determine eligibility for participation. An occupational therapist who is a member of the study team will provide instructions about how to practise fasting.
Adherence to the intervention will be monitored by a self-reported structured diary which has entry for each day.
The total duration of the intervention is six months.
Intervention code [1] 333277 0
Lifestyle
Description of the comparator or control
The comparator intervention is ad-libitum eating (ad-libitum means as one likes meaning consumption of food as wished).
Control group
Active

Outcomes
Primary outcome [1] 344482 0
The primary outcome is the comparison of time-restricted eating feasibility between the experimental and control groups at six months
Timepoint [1] 344482 0
Recruitment will be measured at one month from the first study contact before the trial. Number of participants randomized and retained will be measured at end of six months.
Primary outcome [2] 344679 0
Number of participants with adherence to the trial design (compliance), both the intervention and control status.
Timepoint [2] 344679 0
Six months from the time of randomization
Primary outcome [3] 344680 0
Adverse effects
Timepoint [3] 344680 0
Six months from randomization
Secondary outcome [1] 458011 0
A change in cognitive function
Timepoint [1] 458011 0
Baseline, before the intervention and at the end of six months after randomization.
Secondary outcome [2] 458823 0
Plasma tau, p-217 level and beta-amyloid 42/40 ratio changes between the commencement and the end of the trial
Timepoint [2] 458823 0
Baseline before the intervention and at the end of six months.
Secondary outcome [3] 458824 0
Changes in mood
Timepoint [3] 458824 0
Baseline and at the end of six months
Secondary outcome [4] 458825 0
A change in body-mass index (BMI)
Timepoint [4] 458825 0
Baseline and at the end of six months

Eligibility
Key inclusion criteria
1. Age between 60 years and 80 years (both inclusive).
2. A family history of dementia in an immediate biological family member.
3. Provide a signed and dated informed consent form to participate in the study.
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Presence of dementia and Mild Cognitive Impairment as defined by a score of 31 or less on the Modified Telephone Interview for Cognitive Status (TICS-M) during initial screening or a score less than 26 on the MoCA during in-person assessment.
2. Current major depressive disorder.
3. Existing diagnoses of any neurodegenerative diseases, strokes, and epilepsy.
4. Treatment with insulin or hypoglycemic drugs.
5. Contraindications for regular aerobic exercise (osteoarthritis, cardiac failure, coronary artery disease, serious cardiac arrythmia, such as a history of ventricular tachycardia).
6. Body mass index (BMI) is less than 23.
7. Frailty-Clinical Frailty Scale, category 4-9.
8. Medium and high risk falls as per Falls Risk Assessment Tool (FRAT).
9. Any medical condition that a participant’s general practitioner or the study doctor decides as unfit for time-restricted eating.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
From the time of random sequence generation, the allocation sequence will be concealed from the assigner in a sealed envelope until the moment of assignment. After participants are assigned to a particular group, the third member will conduct baseline and follow-up assessments and implement the intervention. This member of the study group will be blind to the allocation status.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization will be used given the relatively small sample sizes. Block randomization can still ensure equal assignment to each group and 1:1 allocation. Random sequences will be generated using randomizer. One of the study team members who is not involved in participant assessment or direct contact will generate the computer sequence. A second member will assign the random sequence to participants.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Sample Size Estimation
The sample size for this trial is 50, 25 participants in the active intervention and 25 in the control group.
• The relevant primary outcome: feasibility of time-restricted eating.
• The main treatment comparison of interest: ad-libitum diet.
• The assumed control mean or rate: Not relevant for this trial as it is a pilot project.
• The minimum treatment effect for which statistical power is required: yet to be calculated from this trial.
• The estimated underlying variability: yet to be calculated from this trial.
• The estimated underlying proportion: yet to be calculated from this trial.

Population to be analyzed

• Intention to treat population (ITT): Includes any participant randomized into the trial, regardless of whether they received the intervention.

Handling of missing data

Since this is a feasibility study, trial adherence will be reported as proportions of the total numbers recruited and randomized.

Methods of analysis
This feasibility study does not plan any inferential statistics.
List each outcome variable, beginning with the primary outcome, and provide for each
• A definition of the measurement or observation and describe how it is calculated, if not readily apparent:
Descriptive data: The total number of participants who contacted the study team.
The number of participants recruited and excluded with reasons.
The number of participants randomized.
The number of participants with varying degrees of adherence to interventions in each group.
Number of participants remained in the trial until completion in each group.
Number of participants who reported side effects in each group.
Side effects with frequencies in each group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/05/2026
Actual
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
29/01/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 321216 0
Charities/Societies/Foundations
Name [1] 321216 0
Dementia Australia Research Foundation
Country [1] 321216 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 323924 0
None
Name [1] 323924 0
Address [1] 323924 0
Country [1] 323924 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319744 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 319744 0
Ethics committee country [1] 319744 0
Australia
Date submitted for ethics approval [1] 319744 0
01/05/2025
Approval date [1] 319744 0
19/08/2025
Ethics approval number [1] 319744 0
2025-31679-70252-4

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 148258 0
A/Prof Alby Elias
Address 148258 0
The University of Melbourne, Level 2/161 Barry St, Carlton VIC 3053
Country 148258 0
Australia
Phone 148258 0
+61417325223
Fax 148258 0
Email 148258 0
[email protected]
Contact person for public queries
Name 148259 0
Alby Elias
Address 148259 0
Ageing in Wellbeing Team, The University of Melbourne, Level 2/161 Barry St, Carlton VIC 3053
Country 148259 0
Australia
Phone 148259 0
+61390355511
Fax 148259 0
Email 148259 0
[email protected]
Contact person for scientific queries
Name 148260 0
Alby Elias
Address 148260 0
The University of Melbourne, Ageing in Wellbeing Team, Level 2/161 Barry St, Carlton VIC 3053
Country 148260 0
Australia
Phone 148260 0
+61390355511
Fax 148260 0
Email 148260 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The data management plan approved by the ethics committee has no plan for data sharing.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.