A study of time-restricted eating and the risk of Alzheimer’s dementia.

INTERVENTION: 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 si Xmonths. CONDITION: Alzheimer's dementia; ; Alzheimer's dementia Neurological ‐ Dementias PRIMARY OUTCOME: Adverse effects ; [Adverse effects form will be used to screen for commonly expected adverse effects and miscellaneous side effects. ; Commonly experienced side effects: Tiredness, dizziness, irritability, headache, loss of leady mass, and hunger pain. Six months from randomization] Number of participants with adherence to the trial design (compliance), both the intervention and control status.; [Self‐reports of time‐restricted eating as documented in the participant diary. Six months from the time of randomization ] The primary outcome is the comparison of time‐restricted eating feasibility between the experimental and control groups at six months ; [Feasibility will be assessed by calculating the number of participants recruited, randomized, and retained for the trial as per the inclusion criteria specified. ; This outcome will be collected by recording the number of participants recruited, randomized, and retained for the trial on the trail source documents. We keep a source document form where we record the above information. The source document will have the data for each participant so that we can collect the information on how many participants were recruited, randomized, and retained. 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. ] 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. SECONDARY OUTCOME: A change in body‐mass inde X(BMI)[The BMI will be calculated by measuring height and weight. Baseline and at the end of si Xmonths ] A change in cognitive function ; [The secondary outcomes will be assessed by measuring a change in the mean values of ; cognitive function as indicated by the Montreal Cognitive Assessment (MoCA) from the commencement of the trial to the end, with estimation of mean scores and standard deviation. ; Baseline, before the intervention and at the end of si Xmonths after randomization. ] Changes in mood [This will be measured by DASS21 with estimation of mean scores and standard deviation. Baseline and at the end of si Xmonths ] Plasma tau, p‐217 level and beta‐amyloid 42/40 ratio changes between the commencement and the end of the trial ; [Estimation of mean plasma tau, p‐217 level and beta‐amyloid 42/40 ratio with standard deviations. Baseline before the intervention and at the end of si Xmonths. ]