Reduced Carbohydrates + Ketogenic Supplement on Energy Metabolism

Not Applicable

Not yet recruiting

• Conditions: Healthy Aging
• Interventions: Dietary Supplement: reduced carbohydrate menu combined with ketogenic supplement

• Registration Number: NCT06455982
• Lead Sponsor: Université de Sherbrooke

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-06
• Last Update Submitted: 2024-06-06
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Study Start: 2024-09-05
• Primary Completion: 2024-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Delta of before/after the intervention	reduced carbohydrate menu combined with ketogenic supplement	2 months of reduced carbohydrate menu combined with a ketogenic MCT supplement

Primary Outcome Measures

Name	Time	Method
Plasma insulin concentration	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.
Plasma glucose concentration	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	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.

Secondary Outcome Measures

Name	Time	Method
Plasma triglycerides concentration	2 months	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.
Plasma cholesterol concentration	2 months	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.

Trial Locations

Locations (1)

Centre de recherche sur le vieillissement; 🇨🇦 Sherbrooke, Quebec, Canada