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

A Randomised, Double-blind, Placebo-controlled, Parallel Study of the Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals

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.

Study Overview

• Status: Completed
• Conditions: Age-associated Memory Impairment
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Brainphyt high dose

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77843-4253
      • Exercise & Sport Nutrition Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; 4 capsules per day containing 275mg of Maltodextrin	Dietary supplement: Placebo; Participants will take placebo capsules during 3 months
Experimental: BrainPhyt High dose; 4 capsules per day containing 275mg of BrainPhyt	Dietary supplement: Brainphyt high dose; Participants will take BrainPhyt capsules during 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in spatial Working Memory	Mean Span Score in Corsi Blocks module of the COMPASS	From week 0 to week 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Microphyt
• Collaborators: Texas A&M University
• Investigators: Principal Investigator: Richard Kreider, PhD, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; inflammation; Cognitive function; Microalgae
• Other Study ID Numbers: IRB2021-1360F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No