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

NCT05642052 | Completed

• 1 other identifier: 2022-4327
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Glucose Metabolism

Keywords

Nutritional intervention; Glucose monitoring; Reduced carb diet; Energy metabolism; Ketones

Outcome Measures

Primary Outcomes (1)

• Blood glucose concentrations

  in mmol/L

  over 10 days

Secondary Outcomes (2)

• Heart rate

  8 hours a day during 10 days

• Number of steps

  8 hours a day during 10 days

Other Outcomes (1)

• Menu appreciation level

  After le 10 days of low carb diet

Study Arms (2)

10 days control diet

SHAM COMPARATOR

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

10 days low carb diet

ACTIVE COMPARATOR

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

Interventions

low carb diet DIETARY_SUPPLEMENT

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

Also known as: reduced carb menu

10 days low carb diet

Regular diet DIETARY_SUPPLEMENT

Regular diet

Also known as: Control

10 days control diet

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Nestlé Health Science: collaborator

Study Sites (1)

Rearsh Centre on Aging

Sherbrooke, Quebec, J1H4C4, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease; Ketosis

Interventions

Diet

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 8, 2022
• Study Start: November 28, 2022
• Primary Completion: February 28, 2024
• Study Completion: March 28, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)