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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05759910
Other study ID # IRB2021-1360F
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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