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

Not Applicable

Completed

• Conditions: Age-associated Memory Impairment

• Registration Number: NCT05759910
• Lead Sponsor: Microphyt

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-08
• Primary Completion: 2023-10-01
• Status Verified: 2023-11
• Study Completion: 2023-11-01
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in spatial Working Memory	From week 0 to week 12	Mean Span Score in Corsi Blocks module of the COMPASS

Secondary Outcome Measures

Name	Time	Method
Change in executive function	From week 0 to week 4	Mean reaction time and accuracy in Stroop task module of the COMPASS
Change in perceptual and cognitive skills	From week 0 to week 12	Mean reaction time and accuracy in Neurotracker light reaction test
Change in spatial working memory	From week 0 to week 4	Mean Span Score in Corsi Blocks module of the COMPASS
Sleep quality	From week 0 to week 4	Change in Leeds Sleep Evaluation questionnaire from 0 to 10 (low sleep quality)
Mood state	From week 0 to week 12	Change Bond-Lader Mood rating scale from 0 to 10 (low mood state)
Stress level	From week 0 to week 12	Change in Cohen's Perceived Stress Scale from 0 to 40 (high stress)
Change in episodic memory	From week 0 to week 4	Mean reaction time and accuracy in Stroop task module of the COMPASS
Change in attention and vigilance	From week 0 to week 4	Mean reaction time and accuracy in Digit Vigilance Task module of the COMPASS
Inflammation IL-6	from week 0 to week 4	Change Interleukin-6 level (pg/ml)

Trial Locations

Locations (1)

Exercise & Sport Nutrition Lab; 🇺🇸 College Station, Texas, United States