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

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ClinicalTrials.gov Identifier: NCT06022094
Recruitment Status : Completed
First Posted : September 1, 2023
Last Update Posted : June 3, 2024
Sponsor:
Information provided by (Responsible Party):
Université de Sherbrooke

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Aging Other: 2 months of reduced carb menus Not Applicable

Detailed Description:

Finding an effective therapeutic strategy for Alzheimer's disease (AD) is a societal priority, but it also remains a major challenge. With one exception in 2021, no new pharmaceutical treatment for AD has been approved for over 20 years. However, several clinical trials demonstrate the potential of ketogenic interventions to restore brain energy and improve cognition in people with mild cognitive impairment and AD. Recently, the largest and longest clinical trial of its kind shows that compensating for energy deficit in the brain during aging improves brain metabolic and cognitive functioning in people with early AD and could potentially delay AD.

One of the main types of ketogenic intervention is the highly reduced carbohydrate (5-10% of daily energy value compared to a normal value of 50-65%) and very high fat ketogenic diet. Despite the now well-established safety of the ketogenic diet and its therapeutic value in the treatment of epilepsy and type 2 diabetes, the latter remains difficult to implement in because of the compliance challenge. A reduced glycemic load diet where intake of refined carbohydrates and added sugar is restricted is found to be much less restrictive than a ketogenic diet. Phase 1 of this project showed that decreased carbohydrate (sugar) intake may improve long-term glycemic control and compliance compared to more severe carbohydrate restriction. Having better blood glucose control may also be important in decreasing the risk of AD possibly by improving the metabolic profile and/or by promoting the production and use of ketones. However, its effectiveness in helping cognition in the elderly is still unknown and any changes in dietary habits can be addressed with some resistance.

The objective of this project is therefore to answer the following question: does a reduction in carbohydrates of 30 to 50% for 2 months reduce the risk of AD by improving the metabolic profile in people living in a senior residence?

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will eat a reduced carb menu for 2 months
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of a Two-month Carbohydrate-restricted Diet on Energy Metabolism in a Seniors' Residence: The SAGE Study
Actual Study Start Date : September 10, 2023
Actual Primary Completion Date : December 15, 2023
Actual Study Completion Date : May 15, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Delta of before/after the intervention
Data will be collected before and after the reduced carb intervention
 Other: 2 months of reduced carb menus
Participants will eat a reduced carb menu for 2 months
Other Name: R-CHO


Outcome Measures
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Primary Outcome Measures :
  1. Change in blood glucose levels [ Time Frame: 2 months ]
    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. Change in blood ketones levels [ Time Frame: 2 months ]
    Blood ketones will be measured before/after the intervention in people in a senior residence via blood sampling.

  3. Change in blood insulin levels [ Time Frame: 2 months ]
    Blood insulin will be measured before/after the intervention in people in a senior residence via blood sampling.


Secondary Outcome Measures :
  1. Change in blood triglycerides levels, [ Time Frame: 2 months ]
    Blood triglycerides levels will be measured before/after the intervention in people in a senior residence via blood sampling.

  2. Change in blood cholesterol levels [ Time Frame: 2 months ]
    Blood cholesterol levels will be measured before/after the intervention in people in a senior residence via blood sampling.

  3. Change in blood glycated hemoglobin levels [ Time Frame: 2 months ]
    Blood glycated hemoglobin levels will be measured before/after the intervention in people in a senior residence via blood sampling.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022094


Locations
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Canada, Quebec
Research Center on Aging
Sherbrooke, Quebec, Canada, J1H 4C4
Sponsors and Collaborators
Université de Sherbrooke
More Information
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Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT06022094    
Other Study ID Numbers: 2024-5195
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: June 3, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Université de Sherbrooke:
Nutritional intervention
Glucose monitoring
Reduced carb diet
Energy metabolism
Ketones