Clinical trial NCT05642052: Feasibility Study of a Community Pilot Project for the Prevention of Alzheimer's Disease: the KetoHome Study.
Official title: Feasibility Study of a Community Pilot Project for the Prevention of Alzheimer's Disease: the KetoHome Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Glucose Metabolism
Keywords: Nutritional intervention
Glucose monitoring
Reduced carb diet
Energy metabolism
Ketones
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Nestlé Health Science
First posted: 2022-12-08
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All participants will go through 10 days of control diet and 10 days of reduced carb diet.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood glucose concentrations
timeFrame: over 10 days
Secondary outcomes:
measure: Heart rate
timeFrame: 8 hours a day during 10 days
measure: Number of steps
timeFrame: 8 hours a day during 10 days
Other outcomes:
measure: Menu appreciation level
timeFrame: After le 10 days of low carb diet
Locations:
city: Sherbrooke
country: Canada
facility: Rearsh Centre on Aging
state: Quebec
Study officials:
References: