Reduced Carbohydrates + Ketogenic Supplement for Healthy Aging

(SAGE-2 Trial)

Overseen By Camille Vandenberghe

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: T1 diabetic, T2 insulin-dependent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those who have been using certain supplements or diets that increase ketones in the last month.

What data supports the effectiveness of the Reduced Carbohydrates + Ketogenic Supplement treatment for healthy aging?

Research shows that ketogenic diets can help older adults with weight loss, diabetes control, and possibly cancer outcomes. Additionally, combining a ketogenic supplement with a low-carbohydrate diet has been effective in reducing seizures in children, suggesting potential benefits for other conditions. ^{1 2 3 4 5}

Is the Reduced Carbohydrates + Ketogenic Supplement treatment safe for humans?

The ketogenic diet, which is similar to the Reduced Carbohydrates + Ketogenic Supplement treatment, has been studied for various conditions and is generally considered safe for humans. However, some people may experience side effects like changes in blood fat levels, constipation, and fatigue. More research is needed to fully understand its safety, especially in older adults. ^{1 6 7 8 9}

How does the Reduced Carbohydrates + Ketogenic Supplement treatment for healthy aging differ from other treatments?

This treatment is unique because it combines a reduced carbohydrate diet with ketogenic supplements to induce ketosis, which may improve mitochondrial function and provide neuroprotective effects. Unlike other treatments, it specifically targets aging processes and age-related diseases by enhancing energy efficiency and reducing inflammation, potentially extending both healthspan and lifespan. ^{8 10 11 12 13}

Eligibility Criteria

This trial is for older adults living in a senior residence who can read and write French, have good vision and hearing to take cognitive tests, and are available during the study period. It's not for those with very low body weight, severe digestive issues or swallowing problems, uncontrolled low blood sugar, significant recent weight loss, or certain diabetics.

Inclusion Criteria

Available during the intervention period

I am an older adult living in a senior residence.

I can understand, read, and write in French.

Exclusion Criteria

Body mass index < 20

Moderate to severe digestive illnesses that can be aggravated by dietary changes

I have severe difficulty swallowing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a reduced carbohydrate diet paired with a ketogenic product for 2 months

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Reduced Carbohydrates + Ketogenic Supplement

Trial Overview The study is testing how a diet with fewer carbs plus a ketogenic supplement affects blood markers like glucose and ketones, cognition, quality of life, physical activity and overall well-being over two months in seniors.

Participant Groups

Group I: Delta of before/after the intervention Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Nestlé Health Science

Industry Sponsor

Trials

2

Recruited

60+

Findings from Research

In a study of 200 older patients (median age 70) on a ketogenic diet, 67% reported beneficial outcomes, including significant weight loss for 79% of those seeking it, improved glucose control for 54% of those with diabetes, and positive effects on cancer outcomes for 63% of patients pursuing that goal.

While the ketogenic diet showed promise for various health issues in older adults, 15% of participants experienced adverse events, including dyslipidemia and constipation, highlighting the need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients. Almodallal, Y., Cook, K., Lammert, LM., et al.[2023]

A systematic review of 13 clinical studies involving ketogenic diets (KDs) alongside cancer treatments showed that KDs can have beneficial effects on overall survival and progression-free survival in some patients, with four studies reporting positive outcomes.

Adverse events related to the ketogenic diet were mostly minor, indicating that KDs are generally safe to use in conjunction with other oncological therapies, although more rigorous studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diets in medical oncology: a systematic review with focus on clinical outcomes. Klement, RJ., Brehm, N., Sweeney, RA.[2020]

A 6-week ketogenic diet (KD) in 42 healthy adults led to a significant weight loss of 2.0 kg, with good compliance indicated by 97% of days showing urinary ketosis, but resulted in a slight decrease in physical performance, including a 2.4% drop in VO2peak and a 4.1% decrease in peak power.

While the KD did not negatively affect daily activities, it raised concerns for competitive athletes due to the observed decline in endurance capacity, despite improvements in handgrip strength and significant reductions in glucose and insulin levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a 6-week non-energy-restricted ketogenic diet on physical fitness, body composition and biochemical parameters in healthy adults. Urbain, P., Strom, L., Morawski, L., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Low-carbohydrate, high-protein score and mortality in a northern Swedish population-based cohort. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Prospective study of the modified atkins diet in combination with a ketogenic liquid supplement during the initial month. [2017]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Long-Term Effects of a Ketogenic Diet for Cancer. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Ketogenic diets in medical oncology: a systematic review with focus on clinical outcomes. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Potential Synergies of &#946;-Hydroxybutyrate and Butyrate on the Modulation of Metabolism, Inflammation, Cognition, and General Health. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The Therapeutic Potential of Ketogenic Diet Throughout Life: Focus on Metabolic, Neurodevelopmental and Neurodegenerative Disorders. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Ketogenic diets: an historical antiepileptic therapy with promising potentialities for the aging brain. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Impact of a 6-week non-energy-restricted ketogenic diet on physical fitness, body composition and biochemical parameters in healthy adults. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of Aging, Macronutrient Composition and Time-Restricted Feeding on the Fischer344 x Brown Norway Rat Gut Microbiota. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Beneficial Effects of Exogenous Ketogenic Supplements on Aging Processes and Age-Related Neurodegenerative Diseases. [2021]

12. France pubmed.ncbi.nlm.nih.gov

Metabolic response to a ketogenic breakfast in the healthy elderly. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Ketone-Based Metabolic Therapy: Is Increased NAD+ a Primary Mechanism? [2020]