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

Sponsor

Université de Sherbrooke (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05642052

Collaborator

Nestlé Health Science Spain (Industry)

Enrollment

Location

Arms

3.9

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Glucose Metabolism	Dietary Supplement: low carb diet Dietary Supplement: Regular diet	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

All participants will go through 10 days of control diet and 10 days of reduced carb diet.All participants will go through 10 days of control diet and 10 days of reduced carb diet.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 28, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Mar 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: 10 days control diet Participants stay on their regular diet while glucose is continuously monitered, heart rate and number of steps is measured for 10 days.	Dietary Supplement: Regular diet Regular diet Other Names: Control
Active Comparator: 10 days low carb diet Participants will eat a low carb diet while glucose is continuously monitered, heart rate and number of steps is measured for 10 days.	Dietary Supplement: low carb diet low carb meals will be 50% less carbs than the regular meals Other Names: reduced carb menu

Arm

Intervention/Treatment

Sham Comparator: 10 days control diet

Participants stay on their regular diet while glucose is continuously monitered, heart rate and number of steps is measured for 10 days.

Dietary Supplement: Regular diet

Regular diet

Other Names:

Control

Active Comparator: 10 days low carb diet

Participants will eat a low carb diet while glucose is continuously monitered, heart rate and number of steps is measured for 10 days.

Dietary Supplement: low carb diet

low carb meals will be 50% less carbs than the regular meals

Other Names:

reduced carb menu

Outcome Measures

Primary Outcome Measures

Blood glucose concentrations [over 10 days]
in mmol/L

Secondary Outcome Measures

Heart rate [8 hours a day during 10 days]
beats per minutes
Number of steps [8 hours a day during 10 days]

Other Outcome Measures

Menu appreciation level [After le 10 days of low carb diet]
To measure feasability of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.