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

NCT05759910 | Completed

• 1 other identifier: IRB2021-1360F
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-associated Memory Impairment

Keywords

Elderly; Microalgae; Cognitive function; inflammation

Outcome Measures

Primary Outcomes (1)

• Change in spatial Working Memory

  Mean Span Score in Corsi Blocks module of the COMPASS

  From week 0 to week 12

Secondary Outcomes (17)

• Change in spatial working memory

  From week 0 to week 4

• Change in attention and vigilance

  From week 0 to week 12

• Change in attention and vigilance

  From week 0 to week 4

• Change in executive function

  From week 0 to week 12

• Change in executive function

  From week 0 to week 4

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

4 capsules per day containing 275mg of Maltodextrin

Dietary Supplement: Placebo

BrainPhyt High dose

EXPERIMENTAL

4 capsules per day containing 275mg of BrainPhyt

Dietary Supplement: Brainphyt high dose

Interventions

Brainphyt high dose DIETARY_SUPPLEMENT

Participants will take BrainPhyt capsules during 3 months

BrainPhyt High dose

Placebo DIETARY_SUPPLEMENT

Participants will take placebo capsules during 3 months

Placebo group

Eligibility Criteria

• Age: 55 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Microphyt: lead
• Texas A&M University: collaborator

Study Sites (1)

Exercise & Sport Nutrition Lab

College Station, Texas, 77843-4253, United States

Location

Related Publications (1)

• Yoo C, Maury J, Gonzalez DE, Ko J, Xing D, Jenkins V, Dickerson B, Leonard M, Estes L, Johnson S, Chun J, Broeckel J, Pradelles R, Sowinski R, Rasmussen CJ, Kreider RB. Effects of Supplementation with a Microalgae Extract from Phaeodactylum tricornutum Containing Fucoxanthin on Cognition and Markers of Health in Older Individuals with Perceptions of Cognitive Decline. Nutrients. 2024 Sep 5;16(17):2999. doi: 10.3390/nu16172999.

  PMID: 39275314 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Kreider, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 8, 2023
• Study Start: May 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)