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Reduced Carbohydrates + Ketogenic Supplement on Energy Metabolism

Effect of a Reduced Carbohydrates Menu Combined With a Ketogenic Supplement on Energy Metabolism in a Senior Residence: the SAGE-2 Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06455982
Acronym
SAGE-2
Enrollment
30
Registered
2024-06-13
Start date
2024-09-05
Completion date
2025-12-15
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Aging

Keywords

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

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTreduced carbohydrate menu combined with ketogenic supplement

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.

Sponsors

Nestlé Health Science
CollaboratorINDUSTRY
Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention 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)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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; * 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

Design outcomes

Primary

MeasureTime frameDescription
Plasma glucose concentration2 monthsTo 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 concentration2 monthsTo 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 concentration2 monthsTo 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.

Secondary

MeasureTime frameDescription
Plasma triglycerides concentration2 monthsTo 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.
Plasma cholesterol concentration2 monthsTo 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.

Countries

Canada

Contacts

Primary ContactCamille Vandenberghe
camille.vandenberghe@usherbrooke.ca819-780-2220

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026