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

Age-associated Memory Impairment Clinical Trial

— PHAEO-FOUR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05759910
• Other study ID #: IRB2021-1360F
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Microphyt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-associated Memory Impairment

Intervention

Dietary Supplement:
• Brainphyt high dose
Participants will take BrainPhyt capsules during 3 months
• Placebo
Participants will take placebo capsules during 3 months

Locations

Country	Name	City	State
United States	Exercise & Sport Nutrition Lab	College Station	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Microphyt	Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

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