Effect of BrainPhyt, a Microalgae Based Ingredient on Cognitive Function in Healthy Older Subjects

Stress Clinical Trial

— PHAEOSOL-THREE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04832412
• Other study ID #: AFCRO-126
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: May 20, 2023

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 20, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Dietary Supplement
• Fucoxanthin
• Healthy Aging
• Mood
• Neuroprotection
• Sleep
• Stress

Intervention

Dietary Supplement:
• BrainPhyt
BrainPhyt low dose supplementation during 6 months
• 100 % Maltodextrin
100 % Maltodextrin

Locations

Country	Name	City	State
Ireland	Atlantia Clinical Food trial	Cork

Sponsors (2)

Lead Sponsor	Collaborator
Microphyt	Atlantia Food Clinical Trials

Country where clinical trial is conducted

Ireland, 

Outcome

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