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Completed

NCT Number: NCT05642052

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

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.

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Key information

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rearsh Centre on Aging

Sherbrooke, Quebec, J1H4C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

low carb diet

Dietary Supplement

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

Other names: reduced carb menu

Regular diet

Dietary Supplement

Regular diet

Other names: Control

Primary outcomes

  1. Blood glucose concentrations

    Time frame: over 10 days

    in mmol/L

Secondary outcomes

  1. Heart rate

    Time frame: 8 hours a day during 10 days

    beats per minutes

  2. Number of steps

    Time frame: 8 hours a day during 10 days

Other outcomes

  1. Menu appreciation level

    Time frame: After le 10 days of low carb diet

    To measure feasibility of the study

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Nestlé Health Science

Registry information

Acronym: KetoHome

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2022
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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