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

NCT ID: NCT05642052

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-28

Study Completion Date

2024-03-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease Glucose Metabolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

10 days control diet

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

Group Type SHAM_COMPARATOR

Regular diet

Intervention Type DIETARY_SUPPLEMENT

Regular diet

10 days low carb diet

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

Group Type ACTIVE_COMPARATOR

low carb diet

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

low carb diet

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

Intervention Type DIETARY_SUPPLEMENT

Regular diet

Regular diet

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

reduced carb menu Control

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nestlé Health Science

INDUSTRY

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rearsh Centre on Aging

Sherbrooke, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-4327

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dementia Moves: Protocol for a Feasibility Study
NCT06400108 NOT_YET_RECRUITING NA
Cohort Study on Cognitive Decline in Elderly
NCT07093892 NOT_YET_RECRUITING
Biomarkers in a Candian Memory Clinic
NCT06843109 ENROLLING_BY_INVITATION