NCT04832412

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Microphyt · Industry
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BrainPhyt	BrainPhyt low dose supplementation during 6 months
DIETARY_SUPPLEMENT	100 % Maltodextrin	100 % Maltodextrin

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-05-20
• Completion: 2023-05-20
• First posted: 2021-04-05
• Last updated: 2024-12-17

Locations

1 site across 1 country: Ireland