Effect of BrainPhyt, a Microalgae Based Ingredient on Cognitive Function in Healthy Older Subjects (PHAEOSOL-THREE)

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

In developed countries, the acceleration of the general population ageing has been widely described for decades, involving changes in public health policies. Among the health issues arising from this demographic change, the maintenance of cognitive function will be a major challenge in the next years, both in societal and economic terms. In this regard, some pharmacological and behavioural (e.g. physical activity, social involvement, intellectually demanding activities) preventive approaches have been evaluated to improve cognitive function with ageing. Among them, dietary interventions showed a potential interest to prevent cognitive decline during ageing. In this sense, there is a growing interest to find ecological solutions and to meet major societal challenge the use of microalgae as molecule of interest sources is a recent promising approach. Marine environments harbour a huge biological diversity of microalgae that represents a large source of almost untapped bioactive compounds. This biodiversity comprises 200,000 to 2 million species with about 35,000 which are described and 15,000 maintained in culture collections. Microalgae are able to produce bioactive molecules, such as pigments, fatty acids, peptides and sterols. Some of these compounds are unique and specifically found in the marine environment and they could be increasingly used as natural bioactive products for targeted applications. Fucoxanthin is one of the major carotenoid found in microalgae well known for its neuroprotective effect but to our knowledge no human studies were realized.

Thus the objective is to evaluate, in healthy older adults, the effect of a 24-week period of daily supplementation of high and low BrainPhyt, doses on cognitive function parameters (Spatial Working Memory scores, Attention and vigilance, episodic memory, executive function), stress, mood, sleep quality and biomarkers.

Study Overview

• Status: Completed
• Conditions: Stress; Cognitive Impairment; Sleep; Healthy Aging; Mood; Dietary Supplement; Neuroprotection; Fucoxanthin
• Intervention / Treatment: Dietary supplement: BrainPhyt; Dietary supplement: 100 % Maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilya Zhivkovich; Email: ilya.zhivkovich@microphyt.eu
• Study Contact Backup: Name: Jonathan Maury, PhD; Phone Number: 0611150394; Email: jonathan.maury@microphyt.eu

Study Locations

• Ireland
  • Cork, Ireland
    • Atlantia Clinical Food trial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Be able to give written informed consent and to consume the investigational product daily for the duration of the study.
2. Healthy males and females aged ≥ 55 and ≤ 75 years old.
3. Is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance).

4. Have age-related mild cognitive decline, defined as:

   1. Absence of dementia as determined by a score of ≥24 on the Mini Mental State Examination (MMSE).
   2. A score on the MAC-Q of ≥25.
5. Have a self-reported memory complaint.
6. Have an AD8 Dementia Screening Score of <2 (normal cognition).
7. Have a Hospital Anxiety and Depression Scale (HADS) score of ≤7 for both anxiety and depression.
8. Is in general good health, as determined by the investigator
9. Ability to comply with study protocol and complete computerised cognitive testing.
10. Willing to maintain their habitual diet and exercise routines.
11. Willing to maintain consistent sleep duration the evening before study visits.

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, or wish to become pregnant during the study.

2. Female participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:

   1. Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
   2. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
   3. sexual partner(s) is/are exclusively female.
   4. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g. male condom, female diaphragm) or contraceptive pill. The participant must be using this method for at least 1 week following the end of the study.
   5. Use of any non-hormonal intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1 % per year. The participant must have the device inserted at least 2 weeks prior to the first Screening Visit, throughout the study, and 2 weeks following the end of the study.
3. Individuals with dementia or mild cognitive impairment defined as greater than or equal to one standard deviation below the mean for age-matched norms on a standardised memory test
4. Individuals taking the following supplements who are unwilling to undergo a 4-week washout period: Ginkgo biloba, Ginseng, Choline, Taurine, Huperizine A, Acetyl-L-Carnitine, DMAE (Dimethylaminoethanol), Lecithin, Phosphatidylcholine, Phosphatidylderine, DHEA (Dehydroepiandrosterene), Alpha lipoic acid, Bacopa (Brahmi), CDP-choline (Citicoline), Alpha-GPC, Green tea extract, L-Tyrosine, or L-Theanine
5. Chronic use of oral or injectable corticosteroids
6. Untreated psychotic or major depressive disorder
7. Uncontrolled hypertension/diabetes
8. A significant history of cardiovascular complaints (e.g., angina)
9. A significant neurological disease
10. Planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study.
11. History within previous 12 months of alcohol or substance abuse.
12. History of heavy smoking (>1 pack/day) within past 3 months.
13. History of heavy caffeinated beverage consumption (>400 mg caffeine/day) within past 2 weeks.

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
Experimental: BrainPhyt Low dose; 2 capsules of 275mg BrainPhyt for 24 weeks	Dietary supplement: BrainPhyt; BrainPhyt low dose supplementation during 6 months
Placebo Comparator: Placebo; 2 capsules of 275mg Maltodextrin	Dietary supplement: 100 % Maltodextrin; 100 % Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spatial working memory	Change in spatial working memory scores - COMPASS cognitive assessment system	From week 0 to week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention and vigilance	Change in spatial working memory scores - COMPASS cognitive assessment system	From week 0 to week 24
Executive function	Change in Executive function scores - COMPASS cognitive assessment system (Stroop task)	From week 0 to week 24
Episodic memory	Change in Episodic memory scores - COMPASS cognitive assessment system (Picture and word recognition tasks)	From week 0 to week 24
Sleep quality	Change in Leeds sleep evaluation questionnaire score	From week 0 to week 24
Mood state	Change in Bond-Lader Mood Rating scale score	From week 0 to week 24
Stress state	Change in Cohen's Perceived stress scale score	From week 0 to week 24
Spatial working memory	Change in spatial working memory scores - COMPASS cognitive assessment system	From week 0 to week 12
Attention and vigilance	Change in spatial working memory scores - COMPASS cognitive assessment system (Choice reaction time and digit vigilance tasks)	From week 0 to week 12
Executive function	Change in Executive function scores - COMPASS cognitive assessment system (Stroop task)	From week 0 to week 12
Episodic memory	Change in Episodic memory scores - COMPASS cognitive assessment system (Picture and word recognition tasks)	From week 0 to week 12
Sleep quality	Change in Leeds sleep evaluation questionnaire score	From week 0 to week 12
Mood state	Change in Bond-Lader Mood Rating scale score	From week 0 to week 12
Stress state	Change in Cohen's Perceived stress scale score	From week 0 to week 12
Blood TNFa level (pg/ml)	Change in blood TNFa compared to baseline	From week 0 to week 12 and week 24
Blood IFN level (pg/ml)	Change in blood IFN compared to baseline	From week 0 to week 12 and week 24
Blood CRP level (pg/ml)	Change in blood CRP compared to baseline	From week 0 to week 12 and week 24
Blood IL6 level (pg/ml)	Change in blood IL6 compared to baseline	From week 0 to week 12 and week 24
Blood Insulin level (mUI/l)	Change in blood Insulin compared to baseline	From week 0 to week 12 and week 24
Blood HbA1C level (%)	Change in blood HbA1C compared to baseline	From week 0 to week 12 and week 24

Collaborators and Investigators

• Sponsor: Microphyt
• Collaborators: Atlantia Food Clinical Trials
• Investigators: Principal Investigator: Timothy Dinan, Professor, Atlantia Clinical Food Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): May 20, 2023
• Study Completion (Actual): May 20, 2023

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: AFCRO-126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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