Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals (PHAEO-FOUR)

Microphyt

Status: Completed

Conditions: Age-associated Memory Impairment

Treatments: Dietary Supplement: Brainphyt high dose; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05759910

IRB2021-1360F

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 55 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

4 capsules per day containing 275mg of Maltodextrin

Treatment:

Dietary Supplement: Placebo

BrainPhyt High dose

Experimental group

Description:

4 capsules per day containing 275mg of BrainPhyt

Treatment:

Dietary Supplement: Brainphyt high dose