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OpenTrials
Completed

NCT Number: NCT05759910

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.

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Key information

Age range

55 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Exercise & Sport Nutrition Lab

College Station, Texas, 77843-4253, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Absence of dementia as determined by a score of >24 on the Mini Mental State Examination (MMSE).
  • ≤29 or ≤9 on the VPA I and II portions of the Wechsler Memory Scale IV, respectively
  • 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

Treatment and study plan

Brainphyt high dose

Dietary Supplement

Participants will take BrainPhyt capsules during 3 months

Placebo

Dietary Supplement

Participants will take placebo capsules during 3 months

Primary outcomes

  1. Change in spatial Working Memory

    Time frame: From week 0 to week 12

    Mean Span Score in Corsi Blocks module of the COMPASS

Secondary outcomes

  1. Change in spatial working memory

    Time frame: From week 0 to week 4

    Mean Span Score in Corsi Blocks module of the COMPASS

  2. Change in attention and vigilance

    Time frame: From week 0 to week 12

    Mean reaction time and accuracy in Digit Vigilance Task module of the COMPASS

  3. Change in attention and vigilance

    Time frame: From week 0 to week 4

    Mean reaction time and accuracy in Digit Vigilance Task module of the COMPASS

  4. Change in executive function

    Time frame: From week 0 to week 12

    Mean reaction time and accuracy in Stroop task module of the COMPASS

  5. Change in executive function

    Time frame: From week 0 to week 4

    Mean reaction time and accuracy in Stroop task module of the COMPASS

  6. Change in episodic memory

    Time frame: From week 0 to week 12

    Mean reaction time and accuracy in Stroop task module of the COMPASS

  7. Change in episodic memory

    Time frame: From week 0 to week 4

    Mean reaction time and accuracy in Stroop task module of the COMPASS

  8. Change in perceptual and cognitive skills

    Time frame: From week 0 to week 4

    Mean reaction time and accuracy in Neurotracker light reaction test

  9. Change in perceptual and cognitive skills

    Time frame: From week 0 to week 12

    Mean reaction time and accuracy in Neurotracker light reaction test

  10. Stress level

    Time frame: From week 0 to week 4

    Change in Cohen's Perceived Stress Scale from 0 to 40 (high stress)

  11. Stress level

    Time frame: From week 0 to week 12

    Change in Cohen's Perceived Stress Scale from 0 to 40 (high stress)

  12. Sleep quality

    Time frame: From week 0 to week 12

    Change in Leeds Sleep Evaluation questionnaire from 0 to 10 (low sleep quality)

  13. Sleep quality

    Time frame: From week 0 to week 4

    Change in Leeds Sleep Evaluation questionnaire from 0 to 10 (low sleep quality)

  14. Mood state

    Time frame: From week 0 to week 4

    Change Bond-Lader Mood rating scale from 0 to 10 (low mood state)

  15. Mood state

    Time frame: From week 0 to week 12

    Change Bond-Lader Mood rating scale from 0 to 10 (low mood state)

  16. Inflammation IL-6

    Time frame: from week 0 to week 12

    Change Interleukin-6 level (pg/ml)

  17. Inflammation IL-6

    Time frame: from week 0 to week 4

    Change Interleukin-6 level (pg/ml)

Sponsors and collaborators

Lead sponsor

Microphyt

Industry

Collaborators

  • Texas A&M University

Registry information

Official study title

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

Acronym: PHAEO-FOUR

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2023
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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