Ketogenic Medium-Chain Triglycerides + B-Vitamins for Mild Cognitive Impairment

Recruiting at 34 trial locations

Overseen By Monique Bunyan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Société des Produits Nestlé (SPN)

Must not be taking: Antidepressants, Antipsychotics

Disqualifiers: Dementia, Parkinson's, Diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

380 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special nutritional supplement, BrainXpert, containing ketogenic medium-chain triglycerides (a type of fat) and B-vitamins, might improve brain function in people with mild memory issues. Participants will receive either BrainXpert or a placebo, a non-active substance. The trial seeks individuals who have experienced memory problems for over three months but can still manage daily activities. As an unphased trial, this study offers a unique opportunity to contribute to understanding potential new ways to support brain health.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications that are not allowed during the study. You may need to stop some of your current medications before and during the trial, but the specific details are in the protocol.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, participants generally tolerated medium-chain triglyceride (MCT) supplements, such as those in BrainXpert, well. Most did not report serious side effects, though some experienced mild digestive issues like stomach discomfort or gas. Another study found that a ketogenic MCT drink, similar to BrainXpert, improved brain function in individuals with mild memory problems. This suggests a positive effect on the brain, with no major safety concerns reported. These results indicate that BrainXpert is likely safe for most people, though some might experience minor stomach issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BrainXpert because it combines ketogenic medium-chain triglycerides (kMCTs) with B-vitamins, offering a novel approach to managing mild cognitive impairment. Unlike traditional treatments that often include medications like cholinesterase inhibitors or NMDA receptor antagonists, BrainXpert provides an alternative by potentially enhancing brain energy metabolism through kMCTs. This unique mechanism could lead to improved cognitive function by supplying the brain with a more readily available energy source. Additionally, the inclusion of B-vitamins supports overall brain health, which may further enhance cognitive outcomes.

What evidence suggests that BrainXpert might be an effective treatment for mild cognitive impairment?

Research shows that certain fats called ketogenic medium-chain triglycerides (kMCTs) can improve thinking and memory in people with mild memory problems. One study found that a special drink increased ketone levels in the blood, enhancing thinking skills. Another study showed that MCT oil improved memory compared to a dummy treatment. In this trial, participants will receive BrainXpert, which includes kMCTs and B-vitamins, or a placebo. These findings suggest that kMCTs might help the brain by providing a different kind of energy. Additionally, B-vitamins, part of BrainXpert, are known to support brain health and might enhance these benefits. Overall, using kMCTs and B-vitamins together appears promising for aiding memory and thinking in people with mild memory issues. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 60 or older with mild cognitive impairment. They must have memory complaints lasting over 3 months, score below certain levels on memory and naming tests, and have a close contact who can attend key visits. Participants need to understand and sign the consent form.

Inclusion Criteria

I am 60 years old or older.

I have read, understood, and signed the consent form.

I have had memory or thinking problems for more than 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a nutritional intervention of ketogenic medium-chain triglycerides and B-vitamins or placebo for cognitive functioning

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BrainXpert

Trial Overview The COGNIKET-MCI study is testing BrainXpert, a nutritional intervention containing ketogenic medium-chain triglycerides and B-vitamins, against a placebo to see if it improves cognitive functioning in older adults with mild cognitive impairment.

How Is the Trial Designed?

Group I: BrainXpert Active Control 1 Intervention

15 g kMCT + B-vitamins (B3, B6, B9/folic acid, and B12) will be provided in powder format

Group II: Placebo Placebo Group 1 Intervention

high-oleic acid sunflower oil as a calorie-equivalent, non-ketogenic vegetable oil, non added vitamin product will be provided in a powder format .

Who Is Running the Clinical Trial?

Société des Produits Nestlé (SPN)

Lead Sponsor

Trials

349

Recruited

63,400+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06347315

NCT06347315 | Evaluation of the Effects of a Nutritional ... Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8048678/

A ketogenic drink improves cognition in mild ... This kMCT drink improved cognitive outcomes in MCI, at least in part by increasing blood ketone level. These data support further assessment of MCI progression ...

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

Effects of ketogenic diet on cognitive function of patients ... The effect of a 6-month ketogenic medium-chain triglyceride supplement on plasma cardiometabolic and inflammatory markers in mild cognitive impairment.

4. link.springer.com link.springer.com/article/10.1007/s41999-021-00534-z

Mild cognitive impairment: when nutrition helps brain ... This article explores the effect of ketones on metabolic activity in the brain and the mechanisms by which ketogenic medium-chain triglycerides ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1123290/full

Ketogenic interventions in mild cognitive impairment, ... (30) reported significant improvements in cognition associated with supplementation of medium-chain triglyceride (MCT) oil as compared to placebo among ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8919247/

Use of medium chain triglyceride (MCT) oil in subjects with ... The purpose of this study was to use MCT oil supplementation to address some of the gaps in the current literature, including its effect on cognition in ...

7. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.12206

A ketogenic drink improves cognition in mild cognitive ... This kMCT drink improved cognitive outcomes in MCI, at least in part by increasing blood ketone level. These data support further assessment of MCI progression ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06347315?term=AREA%5BConditionSearch%5D(%22Mild%20Cognitive%20Impairment%22)%20AND%20AREA%5BInterventionSearch%5D(%22Hydroxocobalamin%22)&rank=3

Evaluation of the Effects of a Nutritional Intervention ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...