Reduced Carbohydrates + Ketogenic Supplement on Energy Metabolism

Healthy Aging Clinical Trial

— SAGE-2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455982
• Other study ID #: 2025-5533
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 5, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: June 2024
• Source: Université de Sherbrooke
• Contact: Camille Vandenberghe
• Phone: 819-780-2220
• Email: camille.vandenberghe[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Aging

Intervention

Dietary Supplement:
• reduced 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.

Locations

Country	Name	City	State
Canada	Centre de recherche sur le vieillissement	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Nestlé Health Science

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months
Primary	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.	2 months
Primary	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.	2 months
Secondary	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.	2 months
Secondary	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.	2 months