Healthy AgingSAGENCT06022094

Effect of a Two-month Carbohydrate-restricted Diet on Energy Metabolism in a Seniors' Residence

A study testing 2 months of reduced carb menus in people with Healthy Aging, run by Université de Sherbrooke at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Aging
What is being tested?: 2 months of reduced carb menus
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteCanada
Study dates: 10 Sep 2023to 15 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Senior men or women residing in VÜ resident home;
Understand, read and write French;
Possess sufficient visual and auditory acuity to pass the cognitive tests;
Available during the intervention period

Who cannot join

Body mass index < 20;
T1 diabetic;
Insulin-dependent T2 diabetic;
Mini Mental State Exam (MMSE) < 20;
Weight loss >10% in the last 6 months, involuntary or voluntary;
Known and uncontrolled hypoglycaemia;

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Moderate to severe digestive illnesses that may be aggravated by dietary changes;
Severe dysphagia;
Supplementation with medium chain triglycerides oil, ketone salts, ketone ester, adherence to the ketogenic diet, reduced carbohydrate diet, intermittent fasting, or other diet or supplements that may significantly increase ketones in the past month;
Participation in other intervention research projects on nutrition or aimed at metabolic change simultaneously.
Medical condition that could prevent the participant from completing the study according to the doctor's opinion

Trial locations and contacts

1 site in 1 country.

Canada1 site

Research Center on Aging
Sherbrooke, Quebec, J1H 4C4

Other trials in Canada

About this study

Official title: Effect of a Two-month Carbohydrate-restricted Diet on Energy Metabolism in a Seniors' Residence: The SAGE Study

The present study will assess the effects on glucose, ketones and other blood biomarkers fuels, cognition, quality of life, physical activity and well-being of a reduced carbohydrate menu (R-CHO) for 2 months in a population living in a residence for the elderly. This intervention study, identified as the SAGE project (phase 2), follows on from the Ketohome project (phase 1) assessing the feasibility of such a project.

Read the detailed description

Finding an effective therapeutic strategy for Alzheimer's disease (AD) is a societal priority, but it also remains a major challenge. With one exception in 2021, no new pharmaceutical treatment for AD has been approved for over 20 years. However, several clinical trials demonstrate the potential of ketogenic interventions to restore brain energy and improve cognition in people with mild cognitive impairment and AD. Recently, the largest and longest clinical trial of its kind shows that compensating for energy deficit in the brain during aging improves brain metabolic and cognitive functioning in people with early AD and could potentially delay AD.

One of the main types of ketogenic intervention is the highly reduced carbohydrate (5-10% of daily energy value compared to a normal value of 50-65%) and very high fat ketogenic diet. Despite the now well-established safety of the ketogenic diet and its therapeutic value in the treatment of epilepsy and type 2 diabetes, the latter remains difficult to implement in because of the compliance challenge. A reduced glycemic load diet where intake of refined carbohydrates and added sugar is restricted is found to be much less restrictive than a ketogenic diet. Phase 1 of this project showed that decreased carbohydrate (sugar) intake may improve long-term glycemic control and compliance compared to more severe carbohydrate restriction. Having better blood glucose control may also be important in decreasing the risk of AD possibly by improving the metabolic profile and/or by promoting the production and use of ketones. However, its effectiveness in helping cognition in the elderly is still unknown and any changes in dietary habits can be addressed with some resistance.

The objective of this project is therefore to answer the following question: does a reduction in carbohydrates of 30 to 50% for 2 months reduce the risk of AD by improving the metabolic profile in people living in a senior residence?

Conditions: Healthy Aging
Being tested: 2 months of reduced carb menus
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.

2 months of reduced carb menusOther
Also called R-CHO
Participants will eat a reduced carb menu for 2 months

Study groups in NCT06022094
Study group	Role	What they receive
Delta of before/after the intervention	Experimental	Data will be collected before and after the reduced carb intervention Receives: Other: 2 months of reduced carb menus

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Blood Glucose Levels
Blood glucose will be monitored continuously with a real-time continuous glucose monitor (CGM) for two 10-days periods; before/after intervention in people in a senior residence.
Measured: Baseline versus 2 months
Change in Blood Ketones Levels
Blood ketones will be measured before/after the intervention in people in a senior residence via blood sampling.
Measured: Baseline versus 2 months
Change in Blood Insulin Levels
Blood insulin will be measured before/after the intervention in people in a senior residence via blood sampling.
Measured: Baseline versus 2 months

Secondary outcomes (3)

Change in Blood Triglycerides Levels,
Blood triglycerides levels will be measured before/after the intervention in people in a senior residence via blood sampling.
Measured: Baseline versus 2 months
Change in Blood Cholesterol Levels
Blood cholesterol levels will be measured before/after the intervention in people in a senior residence via blood sampling.
Measured: Baseline versus 2 months
Change in Blood Glycated Hemoglobin Levels
Blood glycated hemoglobin levels will be measured before/after the intervention in people in a senior residence via blood sampling.
Measured: Baseline versus 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 202315 May 2024

First posted1 Sep 2023
Study start10 Sep 2023
Primary completion15 Dec 2023
Study completion15 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: All participants will eat a reduced carb menu for 2 months
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06022094
Sponsor's protocol ID: 2024-5195
Acronym: SAGE
Status last verified: Aug 2024
First submitted: 18 Jul 2023
Last updated: 28 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Vandenberghe C, Hardy E, Morin MC, St-Pierre V, Groulx K, Fortier M, Tessier D, Leclerc P, Cunnane SC. A reduced carbohydrate diet improves glycemic regulation in hyperglycemic older people in a retirement home: the SAGE study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-10. doi: 10.1139/apnm-2024-0277. Epub 2024 Oct 4.
PubMed 39366004

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Two-month Carbohydrate-restricted Diet on Energy Metabolism in a Seniors' Residence: The SAGE Study
ClinicalTrials.gov ID: NCT06022094
Acronym / sponsor ID: SAGE / 2024-5195
Conditions: Healthy Aging
Keywords: Nutritional intervention, Glucose monitoring, Reduced carb diet, Energy metabolism, Ketones
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Université de SherbrookeUniversity, hospital or other
Study start: 10 Sep 2023 (actual)
Primary completion: 15 Dec 2023 (actual)
Study completion: 15 May 2024 (actual)
First posted: 1 Sep 2023 (actual)
Results: Posted 28 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All participants will eat a reduced carb menu for 2 months

Arm	Type	Receives
Delta of before/after the intervention	Experimental	Other: 2 months of reduced carb menusData will be collected before and after the reduced carb intervention

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Senior men or women residing in VÜ resident home;
Understand, read and write French;
Possess sufficient visual and auditory acuity to pass the cognitive tests;
Available during the intervention period

Key exclusion criteria (11 listed)

Body mass index < 20;
T1 diabetic;
Insulin-dependent T2 diabetic;
Mini Mental State Exam (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
2 months of reduced carb menusAlso: R-CHOParticipants will eat a reduced carb menu for 2 months	Other	Delta of before/after the intervention

Primary outcome

Change in Blood Glucose Levels
Time frame: Baseline versus 2 months
Blood glucose will be monitored continuously with a real-time continuous glucose monitor (CGM) for two 10-days periods; before/after intervention in people in a senior residence.
Change in Blood Ketones Levels
Time frame: Baseline versus 2 months
Blood ketones will be measured before/after the intervention in people in a senior residence via blood sampling.
Change in Blood Insulin Levels
Time frame: Baseline versus 2 months
Blood insulin will be measured before/after the intervention in people in a senior residence via blood sampling.

3 secondary outcomes

Change in Blood Triglycerides Levels,
Time frame: Baseline versus 2 months
Change in Blood Cholesterol Levels
Time frame: Baseline versus 2 months
Change in Blood Glycated Hemoglobin Levels
Time frame: Baseline versus 2 months

Results and safety

Results posted to the registry on 28 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Change Before and After an Intervention of a 2 Month Reduced Carbohydrate Menu	29	24

Primary outcome: Change in Blood Glucose Levels

Time frame: Baseline versus 2 months. Mean (Standard Deviation). Unit: mmol/L

Measure	Delta of Before/After the Intervention n = 24
Value	-0.1 (0.2)

Primary outcome: Change in Blood Ketones Levels

Time frame: Baseline versus 2 months. Mean (Standard Deviation). Unit: umol/L

Measure	Delta of Before/After the Intervention n = 24
Value	64 (117)

Primary outcome: Change in Blood Insulin Levels

Time frame: Baseline versus 2 months. Mean (Standard Deviation). Unit: pmol/L

Measure	Delta of Before/After the Intervention n = 24
Value	-3.5 (0.2)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delta of Before/After the Intervention	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39366004Vandenberghe C, Hardy E, Morin MC, St-Pierre V, Groulx K, Fortier M, Tessier D, Leclerc P, Cunnane SC. A reduced carbohydrate diet improves glycemic regulation in hyperglycemic older people in a retirement home: the SAGE study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-10. doi: 10.1139/apnm-2024-0277. Epub 2024 Oct 4.
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 2 months of reduced carb menus 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: finished, as of the sponsor's last update on 28 Oct 2026. 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?

Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Blood Glucose Levels (time frame: Baseline versus 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?

On the ClinicalTrials.gov record for NCT06022094, which also lists 1 linked publication.

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 28 Oct 2026.