Feasibility Study of a Community Pilot Project for the Prevention of Alzheimer's Disease: the KetoHome Study.

Study Overview
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Brief Summary
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The purpose of this study is to assess whether it is possible to carry out a research project with a nutritional intervention in senior's residence. Life in a small community is very different and above all unique, which could be an asset in a research setting.

Detailed Description
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To ensure its functioning, the brain needs a lot of energy. However, during aging, it has difficulty properly using its main fuel, sugar. The brain then becomes starved. This energy deficit is part of the vicious circle leading to memory problems. The brain, like a hybrid car, can run on two fuels, sugar and ketones. Providing alternative fuel to the brain, in the form of ketones, and thus offsetting the energy it needs, could improve its functioning and help prevent or improve memory problems. There are several ways to increase ketones in our body such as certain dietary oils, natural health products, physical activity or certain diets. Reducing the amount of sugar in our diet is also a strategy that can increase ketones. A low-sugar diet is already widely used in the prevention of several important diseases, including type 2 diabetes and even Alzheimer's disease. This study will assess the feasibility of a community intervention project in a seniors' residence with the eventual overall objective of slowing the progression or onset of AD and related health indicators, through a dietary modification. This feasibility study will last 6 months. The basic characteristics of interested participants will be collected. The global spheres of evaluation are the following: metabolic profile, cognition, quality of life and nutritional status. Glucose measurements will be taken continuously via a sensor over two weeks during the project.

Official Title
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Feasibility Study of a Community Pilot Project for the Prevention of Alzheimer's Disease: the KetoHome Study.

Conditions
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Alzheimer Disease, Glucose Metabolism

Intervention / Treatment
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* Dietary Supplement: low carb diet
* Dietary Supplement: Regular diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older men or women resident of Grace Village and resident of Vü; Understand, read and write French or English; Possess sufficient visual and auditory acuity to pass the cognitive tests. Exclusion Criteria: The minimum possible criteria ensuring the safety of voluntary participants. The family doctor will need to confirm eligibility. Body mass index < 22 Malnutrition. High risk of hypoglycaemia Moderate to severe digestive diseases that can be aggravated by dietary changes Severe dysphagia Supplementation with MCT oil, ketone salts, ketone ester, adherence to the ketogenic diet, intermittent fasting, or other diet or supplements that may significantly increase ketones; Participation in other intervention research projects on nutrition or aimed at metabolic change simultaneously.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will go through 10 days of control diet and 10 days of reduced carb diet.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 10 days control diet<br>Participants stay on their regular diet while glucose is continuously monitored, heart rate and number of steps is measured for 10 days. | Dietary Supplement: Regular diet<br>* Regular diet<br>* Other names: Control;|
| Active Comparator: 10 days low carb diet<br>Participants will eat a low carb diet while glucose is continuously monitored, heart rate and number of steps is measured for 10 days. | Dietary Supplement: low carb diet<br>* low carb meals will be 50% less carbs than the regular meals<br>* Other names: reduced carb menu;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose concentrations | in mmol/L | over 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | beats per minutes | 8 hours a day during 10 days | 
| Number of steps |  | 8 hours a day during 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional intervention, Glucose monitoring, Reduced carb diet, Energy metabolism, Ketones