Healthy AgingSAGE-2NCT06455982
Reduced Carbohydrates + Ketogenic Supplement on Energy Metabolism
A study testing reduced carbohydrate menu combined with ketogenic supplement in people with Healthy Aging, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The present study will evaluate the effects on glucose, ketones and other blood biomarkers, cognition, quality of life, physical activity and well-being of a reduced carbohydrate diet paired with a ketogenic product for 2 months in a population living in a senior residence. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- reduced carbohydrate menu combined with ketogenic supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 5 Sep 2024to 15 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older men or women in a senior residence;
- Understand, read and write French;
- Have sufficient visual and hearing acuity to pass cognitive tests;
- Available during the intervention period
Who cannot join
- Body mass index < 20;
- T1 diabetic;
- T2 insulin-dependent diabetic;
- MMSE < 20;
- Weight loss >10% in the last 6 months involuntary or voluntary;
- Known and uncontrolled hypoglycemia;
Show all 11Show fewer
- Moderate to severe digestive illnesses that can be aggravated by dietary changes;
- Severe dysphagia;
- Supplementation with MCT oil, ketone salts, ketone esters, adherence to the ketogenic diet, reduced carbohydrate diet, intermittent fasting or other diet or supplements that can significantly increase ketones in the last month;
- Participation in other interventional research projects on nutrition or aimed at metabolic change simultaneously.
- Medical condition that could prevent the participant from completing the study in the opinion of the doctor
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, J1H 4C4
Camille Vandenberghe, M.Sc, 819-780-2220 ext. 45235, camille.vandenberghe@usherbrooke.ca
Stephen C Cunnane, PhD
About this study
Official title: Effect of a Reduced Carbohydrates Menu Combined With a Ketogenic Supplement on Energy Metabolism in a Senior Residence: the SAGE-2 Study
The present study will evaluate the effects on glucose, ketones and other blood biomarkers, cognition, quality of life, physical activity and well-being of a reduced carbohydrate diet paired with a ketogenic product for 2 months in a population living in a senior residence. This study follows the KetoHome (fall 2022) and SAGE (fall 2023) projects which assessed the feasibility, acceptability and effectiveness of a reduced carbohydrate intervention alone.
- Conditions
- Healthy Aging
- Being tested
- reduced carbohydrate menu combined with ketogenic supplement
- Keywords
- Nutritional intervention, Glucose monitoring, Reduced carb diet, Energy metabolism, Ketones
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduced carbohydrate menu combined with ketogenic supplementDietary supplement
Also called RCHO+MCT
Participants will eat a reduced carb menu for 2 months and they will take 15g of MCT in the morning and the evening for a total of 30g per day.
| Study group | Role | What they receive |
|---|---|---|
| Delta of before/after the intervention | Experimental | 2 months of reduced carbohydrate menu combined with a ketogenic MCT supplement Receives: Dietary Supplement: reduced carbohydrate menu combined with ketogenic supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose concentration
To evaluate the possible improvement in mean glucose concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.
Measured: 2 months
Plasma ketones concentration
To evaluate the possible improvement in mean ketones concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.
Measured: 2 months
Plasma insulin concentration
To evaluate the possible improvement in mean insulin concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.
Measured: 2 months
Secondary outcomes (2)
Plasma triglycerides concentration
To evaluate the possible improvement in mean triglycerides concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.
Measured: 2 months
Plasma cholesterol concentration
To evaluate the possible improvement in mean cholesterol concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start5 Sep 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be compared to themselve (i.e. pre-intervention and post-intervention) The intervention will be 2 months of reduced carbohydrate menu combined with a ketogenic supplement (MCT)
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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
- NCT06455982
- Sponsor's protocol ID
- 2025-5533
- Acronym
- SAGE-2
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Reduced Carbohydrates Menu Combined With a Ketogenic Supplement on Energy Metabolism in a Senior Residence: the SAGE-2 Study
- ClinicalTrials.gov ID
- NCT06455982
- Acronym / sponsor ID
- SAGE-2 / 2025-5533
- Conditions
- Healthy Aging
- Keywords
- Nutritional intervention, Glucose monitoring, Reduced carb diet, Energy metabolism, Ketones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Nestlé Health Science
- Study start
- 5 Sep 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 13 Jun 2024 (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 present study will evaluate the effects on glucose, ketones and other blood biomarkers, cognition, quality of life, physical activity and well-being of a reduced carbohydrate diet paired with a ketogenic product for 2 months in a population living in a senior residence. This study follows the KetoHome (fall 2022) and SAGE (fall 2023) projects which assessed the feasibility, acceptability and effectiveness of a reduced carbohydrate intervention alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be compared to themselve (i.e. pre-intervention and post-intervention) The intervention will be 2 months of reduced carbohydrate menu combined with a ketogenic supplement (MCT)
| Arm | Type | Receives |
|---|---|---|
| Delta of before/after the intervention | Experimental | Dietary Supplement: reduced carbohydrate menu combined with ketogenic supplement2 months of reduced carbohydrate menu combined with a ketogenic MCT supplement |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older men or women in a senior residence;
- Understand, read and write French;
- Have sufficient visual and hearing acuity to pass cognitive tests;
- Available during the intervention period
Key exclusion criteria (11 listed)
- Body mass index < 20;
- T1 diabetic;
- T2 insulin-dependent diabetic;
- MMSE < 20;
- Weight loss >10% in the last 6 months involuntary or voluntary;
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 |
|---|---|---|
| reduced carbohydrate menu combined with ketogenic supplementAlso: RCHO+MCTParticipants will eat a reduced carb menu for 2 months and they will take 15g of MCT in the morning and the evening for a total of 30g per day. | Dietary supplement | Delta of before/after the intervention |
Primary outcome
Plasma glucose concentration
Time frame: 2 months
To evaluate the possible improvement in mean glucose concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.
Plasma ketones concentration
Time frame: 2 months
To evaluate the possible improvement in mean ketones concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.
Plasma insulin concentration
Time frame: 2 months
To evaluate the possible improvement in mean insulin concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.
2 secondary outcomes
Plasma triglycerides concentration
Time frame: 2 months
Plasma cholesterol concentration
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reduced carbohydrate menu combined with ketogenic supplement in people with Healthy Aging, 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Jun 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camille Vandenberghe (819-780-2220 ext. 45235, camille.vandenberghe@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose concentration (time frame: 2 months). The study lists 3 primary outcomes in all. 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 13 Jun 2024.