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

NCT06022094 | Completed

• 1 other identifier: 2024-5195
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Aging

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  2 months

Secondary Outcomes (3)

• Change in blood triglycerides levels,

  2 months

• Change in blood cholesterol levels

  2 months

• Change in blood glycated hemoglobin levels

  2 months

Study Arms (1)

Delta of before/after the intervention

EXPERIMENTAL

Data will be collected before and after the reduced carb intervention

Other: 2 months of reduced carb menus

Interventions

2 months of reduced carb menus OTHER

Participants will eat a reduced carb menu for 2 months

Also known as: R-CHO

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:

• 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

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Research Center on Aging

Sherbrooke, Quebec, J1H 4C4, Canada

Location

Related Publications (1)

• 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.

  PMID: 39366004 DERIVED

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

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

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: All participants will eat a reduced carb menu for 2 months

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: September 1, 2023
• Study Start: September 10, 2023
• Primary Completion: December 15, 2023
• Study Completion: May 15, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)