Reduced Carbohydrates + Ketogenic Supplement on Energy Metabolism

NCT06455982 | Not Yet Recruiting

• 1 other identifier: 2025-5533
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Aging

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Plasma triglycerides concentration

  2 months

• Plasma cholesterol concentration

  2 months

Study Arms (1)

Delta of before/after the intervention

EXPERIMENTAL

2 months of reduced carbohydrate menu combined with a ketogenic MCT supplement

Dietary Supplement: reduced carbohydrate menu combined with ketogenic supplement

Interventions

reduced carbohydrate menu combined with ketogenic supplement DIETARY_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.

Also known as: RCHO+MCT

Delta of before/after the intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Nestlé Health Science: collaborator

Study Sites (1)

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

Location

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Camille Vandenberghe

CONTACT

819-780-2220; camille.vandenberghe@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 13, 2024
• Study Start: September 5, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

CA (1)