Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI)

Part of paid clinical trials in Miami, Florida.

Sponsor
Société des Produits Nestlé (SPN)
Study ID
NCT06347315
Status
Recruiting
Apply to this trial

Conditions

  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BrainXpert — DIETARY_SUPPLEMENT
    sachet/stickpack of 25 g, has no preservatives, no flavors, no sweeteners, and no colorants.
  • Placebo — OTHER
    high-oleic acid sunflower oil as a calorie-equivalent, non-ketogenic vegetable oil, non added vitamin product will also be provided in a powder format in a sachet/stickpack of 25 g.

Study Details

Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI)

Key Dates

Start date
May 24, 2024
Status verified
Aug 2025
Primary completion
Dec 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
380 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: BrainXpert
    15 g kMCT + B-vitamins (B3, B6, B9/folic acid, and B12) will be provided in powder format
  • Placebo Comparator: Placebo
    high-oleic acid sunflower oil as a calorie-equivalent, non-ketogenic vegetable oil, non added vitamin product will be provided in a powder format .

Primary Outcome Measure

Preclinical Alzheimer's Cognitive Composite (PACC) score [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stein Gerontological Institute IncMiamiFlorida33137
Marc Edward Agronin, Dr
[email protected]
305-762-1487
University of RochesterRochesterNew York14620
Anton Porsteinsson, Dr
[email protected]
585-602-5201

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By research site
Stein Gerontological Institute Inc· Miami, FLUniversity of Rochester· Rochester, NY

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