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

Alzheimer Disease Clinical Trial

— KetoHome  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05642052
• Other study ID #: 2022-4327
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 28, 2022
• Est. completion date: March 28, 2024

Study information

• Verified date: July 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: March 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Glucose Metabolism

Intervention

Dietary Supplement:
• low carb diet
low carb meals will be 50% less carbs than the regular meals
• Regular diet
Regular diet

Locations

Country	Name	City	State
Canada	Rearsh Centre on Aging	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Nestlé Health Science Spain

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Menu appreciation level	To measure feasibility of the study	After le 10 days of low carb diet
Primary	Blood glucose concentrations	in mmol/L	over 10 days
Secondary	Heart rate	beats per minutes	8 hours a day during 10 days
Secondary	Number of steps		8 hours a day during 10 days