Alzheimer DiseaseKetoHomeNCT05642052
Feasibility Study of a Community Pilot Project for the Prevention of Alzheimer's Disease: the KetoHome Study.
A study testing low carb diet and Regular diet in people with Alzheimer Disease and Glucose Metabolism, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Glucose Metabolism
- What is being tested?
- low carb diet and Regular diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 28 Nov 2022to 28 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Alzheimer Disease, Glucose Metabolism
- Being tested
- low carb diet, Regular diet
- Keywords
- Nutritional intervention, Glucose monitoring, Reduced carb diet, Energy metabolism, Ketones
- Medical subject headings
- Alzheimer Disease, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low carb dietDietary supplement
Also called reduced carb menu
low carb meals will be 50% less carbs than the regular meals
Regular dietDietary supplement
Also called Control
Regular diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: low carb diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose concentrations
in mmol/L
Measured: over 10 days
Secondary outcomes (2)
Heart rate
beats per minutes
Measured: 8 hours a day during 10 days
Number of steps
Measured: 8 hours a day during 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start28 Nov 2022
- Primary completion28 Feb 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All participants will go through 10 days of control diet and 10 days of reduced carb diet.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Health Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642052
- Sponsor's protocol ID
- 2022-4327
- Acronym
- KetoHome
- Status last verified
- May 2024
- First submitted
- 29 Nov 2022
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Community Pilot Project for the Prevention of Alzheimer's Disease: the KetoHome Study.
- ClinicalTrials.gov ID
- NCT05642052
- Acronym / sponsor ID
- KetoHome / 2022-4327
- Conditions
- Alzheimer Disease, Glucose Metabolism
- Keywords
- Nutritional intervention, Glucose monitoring, Reduced carb diet, Energy metabolism, Ketones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Nestlé Health Science
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will go through 10 days of control diet and 10 days of reduced carb diet.
| Arm | Type | Receives |
|---|---|---|
| 10 days control diet | Sham comparator | Dietary Supplement: Regular dietParticipants stay on their regular diet while glucose is continuously monitored, heart rate and number of steps is measured for 10 days. |
| 10 days low carb diet | Active comparator | Dietary Supplement: low carb dietParticipants will eat a low carb diet while glucose is continuously monitored, heart rate and number of steps is measured for 10 days. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low carb dietAlso: reduced carb menulow carb meals will be 50% less carbs than the regular meals | Dietary supplement | 10 days low carb diet |
| Regular dietAlso: ControlRegular diet | Dietary supplement | 10 days control diet |
Primary outcome
Blood glucose concentrations
Time frame: over 10 days
in mmol/L
2 secondary outcomes
Heart rate
Time frame: 8 hours a day during 10 days
Number of steps
Time frame: 8 hours a day during 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low carb diet and Regular diet in people with Alzheimer Disease and Glucose Metabolism, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose concentrations (time frame: over 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.