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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how a low-carb diet combined with a special ketogenic supplement affects health in older adults. Researchers will monitor blood sugar, brain function, and overall well-being over two months. The trial targets seniors living in a residence who can read and write French, have good vision and hearing for tests, and are available for the study period. As an unphased trial, participants contribute to valuable research that may enhance health outcomes for seniors.

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 prior data suggests that this reduced carbohydrate diet paired with a ketogenic supplement is safe for healthy aging?

Research has shown that a ketogenic diet, low in carbohydrates, is generally well-tolerated by older adults. In one study with 200 older participants, 67% reported positive results, and 79% of these individuals lost a significant amount of weight. This suggests the diet can be helpful for many people.

However, awareness of possible side effects is important. Some studies indicate that a low-carb, high-fat diet might raise certain cholesterol levels, potentially affecting heart health. While many find the diet beneficial, considering these potential risks is crucial, especially for those with existing health issues. Consulting a healthcare provider before making significant dietary changes is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of a reduced carbohydrate diet and a ketogenic supplement for healthy aging because it offers a novel approach to managing aging-related health conditions. Unlike traditional treatments that may focus on exercise or medication to promote healthy aging, this approach leverages dietary changes and a ketogenic medium-chain triglyceride (MCT) supplement to potentially improve metabolic health and energy levels. The use of a ketogenic supplement aims to enhance ketone production in the body, providing an alternative energy source for cells, which may lead to improved cognitive function and overall vitality. This dietary strategy could be a more accessible and sustainable option for individuals seeking to support healthy aging through lifestyle modifications.

What evidence suggests that this treatment might be an effective treatment for healthy aging?

Research has shown that eating fewer carbohydrates and taking a ketogenic supplement can aid in healthy aging. In this trial, participants will follow a reduced carbohydrate menu combined with a ketogenic MCT supplement. In a study of 200 older adults on a ketogenic diet, 67% reported positive results, with 79% experiencing significant weight loss. Other studies have found that low-carb, ketogenic diets can help control blood sugar levels and reduce the need for diabetes medications. Consuming very few carbohydrates has also been linked to improved memory in older adults with mild memory problems. Evidence suggests that ketogenic diets may lower the risk of dying from any cause without increasing heart problems. These findings indicate that this approach can support various aspects of health in older adults. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Have sufficient visual and hearing acuity to pass cognitive tests

Exclusion Criteria

Body mass index < 20

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

I have severe difficulty swallowing.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-healthy-aging-8-2024-dc42f

Reduced Carbohydrates + Ketogenic Supplement for ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10574428/

Ketogenic Diet and Multiple Health Outcomes: An Umbrella ... Previous studies have shown that taking an LCKD has beneficial effects on blood sugar control, weight and the use of hypoglycemic drugs in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1279770724003932

Effects of ketogenic diet on cognitive function of patients ... A study by Grochowska [22] found that very low carbohydrate consumption, which induces ketosis, can improve memory function in older adults with mild cognitive ...

4. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-023-02874-y

Effects of ketogenic diet on health outcomes: an umbrella ... K-LCHF was associated with reduced body weight and body fat percentage, but also reduced muscle mass in healthy participants. Conclusions. This ...

5. nature.com nature.com/articles/s41598-024-73384-x

The ketogenic diet has the potential to decrease all-cause ... The findings demonstrate that the KD shows promise in reducing overall mortality risk without a concurrent increase in cardiovascular-related ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK499830/

Ketogenic Diet - StatPearls - NCBI Bookshelf These findings indicate that a ketogenic diet may effectively reduce the risk of heart disease.

7. clinconnect.io clinconnect.io/trials/NCT06455982

Reduced Carbohydrates + Ketogenic Supplement on Energy This clinical trial is looking at how a diet with reduced carbohydrates, combined with a special ketogenic supplement, affects healthy aging in older adults ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11511599/

Ketogenic Diet: A Review of Composition Diversity ... The ketogenic diet (KD) is a special high-fat, very low-carbohydrate diet with the amount of protein adjusted to one's requirements.

9. nature.com nature.com/articles/s41392-021-00831-w

Ketogenic diet for human diseases: the underlying ... A low-carbohydrate, high-protein, and high-fat diet can be unhealthy as it may lead to an increase in the circulating low-density lipoprotein ( ...