Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-11-01

Brief Summary

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The purpose of this study is to evaluate if BrainPhyt, a microalgae based ingredient may affect cognitive function parameters in older healthy individuals with evidence of age-related cognitive decline.

In a double blind, randomized manner, 40 free living males and females between 55 to 75 years with age-associated memory decline will ingest Brainphyt supplement or Placebo for 12 weeks. Cognitive function battery will be realized after 4 and 12 weeks of supplementation.

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Detailed Description

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Conditions

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Age-associated Memory Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo group

4 capsules per day containing 275mg of Maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Participants will take placebo capsules during 3 months

BrainPhyt High dose

4 capsules per day containing 275mg of BrainPhyt

Group Type EXPERIMENTAL

Brainphyt high dose

Intervention Type DIETARY_SUPPLEMENT

Participants will take BrainPhyt capsules during 3 months

Interventions

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Brainphyt high dose

Participants will take BrainPhyt capsules during 3 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Participants will take placebo capsules during 3 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Be able to give written informed consent and to consume the investigational product daily for the duration of the study.
* Healthy males and females aged ≥ 55 and ≤ 75 years old.
* Body-mass index between 18.5 and 35.0 kg/m2
* Is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance).
* Have age-associated memory impairment (AAMI) based on the following National Institute of Mental Health criteria, specified as scoring:

1. Absence of dementia as determined by a score of \>24 on the Mini Mental State Examination (MMSE).
2. ≤29 or ≤9 on the VPA I and II portions of the Wechsler Memory Scale IV, respectively
3. A score on the MAC-Q of ≥25.
* Is in general good health, as determined by the investigator
* Ability to comply and understand the cognitive function practice tests
* Willing to maintain their habitual diet and exercise routines.
* Willing to maintain consistent sleep duration the evening before study visits.

Exclusion Criteria

* Use of medications or supplements known to alter cognitive function within past 2 weeks
* Abnormal clinical laboratory test that may affect study outcome.
* History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, gastrointestinal, pancreatic, or neurological disorders (including sleep disorders, head injuries, Alzheimer's disease, Parkinson's disease, stroke, inflammatory brain disease
* History or presence of cancer, except nonmelanoma skin cancer
* Uncontrolled hypertension/diabetes
* History of depression within past 24 months or use of psychotropic medications within 1 month of screening
* Planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study.
* History within previous 12 months of alcohol or substance abuse.
* History of heavy smoking (\>1 pack/day) within past 3 months

Minimum Eligible Age

55 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes