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

Primary Purpose

Alzheimer Disease, Glucose Metabolism

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
low carb diet
Regular diet
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease focused on measuring Nutritional intervention, Glucose monitoring, Reduced carb diet, Energy metabolism, Ketones

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rearsh Centre on Aging

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

10 days control diet

10 days low carb diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Blood glucose concentrations
in mmol/L

Secondary Outcome Measures

Heart rate
beats per minutes
Number of steps

Full Information

First Posted
November 29, 2022
Last Updated
July 18, 2023
Sponsor
Université de Sherbrooke
Collaborators
Nestlé Health Science Spain
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1. Study Identification

Unique Protocol Identification Number
NCT05642052
Brief Title
Feasibility Study of a Community Pilot Project for the Prevention of Alzheimer's Disease: the KetoHome Study.
Acronym
KetoHome
Official Title
Feasibility Study of a Community Pilot Project for the Prevention of Alzheimer's Disease: the KetoHome Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
March 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
Collaborators
Nestlé Health Science Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Glucose Metabolism
Keywords
Nutritional intervention, Glucose monitoring, Reduced carb diet, Energy metabolism, Ketones

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will go through 10 days of control diet and 10 days of reduced carb diet.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 days control diet
Arm Type
Sham Comparator
Arm Description
Participants stay on their regular diet while glucose is continuously monitored, heart rate and number of steps is measured for 10 days.
Arm Title
10 days low carb diet
Arm Type
Active Comparator
Arm Description
Participants will eat a low carb diet while glucose is continuously monitored, heart rate and number of steps is measured for 10 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
low carb diet
Other Intervention Name(s)
reduced carb menu
Intervention Description
low carb meals will be 50% less carbs than the regular meals
Intervention Type
Dietary Supplement
Intervention Name(s)
Regular diet
Other Intervention Name(s)
Control
Intervention Description
Regular diet
Primary Outcome Measure Information:
Title
Blood glucose concentrations
Description
in mmol/L
Time Frame
over 10 days
Secondary Outcome Measure Information:
Title
Heart rate
Description
beats per minutes
Time Frame
8 hours a day during 10 days
Title
Number of steps
Time Frame
8 hours a day during 10 days
Other Pre-specified Outcome Measures:
Title
Menu appreciation level
Description
To measure feasibility of the study
Time Frame
After le 10 days of low carb diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Rearsh Centre on Aging
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H4C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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