Clinical trial NCT05759910: Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Study of the Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-associated Memory Impairment
Keywords: Elderly
Microalgae
Cognitive function
inflammation
Lead sponsor: Microphyt
Sponsor class: INDUSTRY
Collaborators: name: Texas A&M University
First posted: 2023-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in spatial Working Memory
timeFrame: From week 0 to week 12
Secondary outcomes:
measure: Change in spatial working memory
timeFrame: From week 0 to week 4
measure: Change in attention and vigilance
timeFrame: From week 0 to week 12
measure: Change in attention and vigilance
timeFrame: From week 0 to week 4
measure: Change in executive function
timeFrame: From week 0 to week 12
measure: Change in executive function
timeFrame: From week 0 to week 4
measure: Change in episodic memory
timeFrame: From week 0 to week 12
measure: Change in episodic memory
timeFrame: From week 0 to week 4
measure: Change in perceptual and cognitive skills
timeFrame: From week 0 to week 4
measure: Change in perceptual and cognitive skills
timeFrame: From week 0 to week 12
measure: Stress level
timeFrame: From week 0 to week 4
measure: Stress level
timeFrame: From week 0 to week 12
measure: Sleep quality
timeFrame: From week 0 to week 12
measure: Sleep quality
timeFrame: From week 0 to week 4
measure: Mood state
timeFrame: From week 0 to week 4
measure: Mood state
timeFrame: From week 0 to week 12
measure: Inflammation IL-6
timeFrame: from week 0 to week 12
measure: Inflammation IL-6
timeFrame: from week 0 to week 4
Other outcomes:
Locations:
city: College Station
country: United States
facility: Exercise & Sport Nutrition Lab
state: Texas
Study officials:
affiliation: Texas A&M University
name: Richard Kreider, PhD
role: PRINCIPAL_INVESTIGATOR
References: