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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Glucose Metabolism
• Intervention / Treatment: Dietary supplement: Regular diet; Dietary supplement: low carb diet

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H4C4
      • Rearsh Centre on Aging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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.	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 monitored, 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menu appreciation level	To measure feasibility of the study	After le 10 days of low carb diet

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Nestle Health Science

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): March 28, 2024

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Ketones; Energy metabolism; Nutritional intervention; Glucose monitoring; Reduced carb diet
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 2022-4327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No