Haematococcus Pluvialis Astaxanthin for Brain Aging

NCT07379437 | Not Yet Recruiting

• 1 other identifier: CNS-NCL2024-04
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

We recruit community-dwelling older adults aged 50 and above for a 6-month intervention. Participants are divided into three groups: Placebo Group, Low-Dose Group ( 6 mg/d Haematococcus pluvialis Astaxanthin), High-Dose Group (12 mg/d Haematococcus pluvialis Astaxanthin). Peripheral blood samples and Other tests are collected at baseline, 3 months, and 6 months to measure mitochondrial function and oxidative stress levels. Assessments include: 1.Cognitive \& Neurophysiological Assessment: Using the MoCA (Montreal Cognitive Assessmentscale) and ERP (specifically P300) monitoring. 2.Brain Imaging: MRI (Magnetic resonance imaging) is used to analyze changes in brain function. 3.Metabolomics: A series of laboratory techniques are used to analyze routine metabolic indices, plasma astaxanthin, mitochondrial function, oxidative stress markers, and cognition-related neurobiomarkers.

Conditions

Brain Aging

Outcome Measures

Primary Outcomes (2)

• Montreal Cognitive Assessment, MoCA

  The cognitive domains assessed included attention and concentration, executive function, memory, language, visual structural skills, abstract thinking, as well as calculation and orientation. The total score of the scale was 30 points.A total score of 26 or above is considered normal (as there is no current Chinese reliability and validity analysis, so the original foreign language threshold values can be temporarily referred to); a score of 19 to 25 indicates that there is a possibility of mild cognitive impairment (MCI); if the score is 19 to 22 and there is also some difficulty in daily life/activities, it usually means that the person has progressed from MCI to dementia; those with a score below 19 can clearly be diagnosed as having dementia.

  From enrollment to the end of treatment at 6 months

• Neurophysiology changes

  The event-related potential (ERP) P300 was used to track the changes of the brain's neural electrophysiology during the cognitive process.Patients with cognitive decline and Alzheimer's disease show an extended P300 latency period.

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (1)

• MRI（Magnetic resonance imaging）

  From enrollment to the end of treatment at 6 months

Study Arms (3)

Placebo Group

PLACEBO COMPARATOR

Placebo

Other: Placebo

Low-Dose AST Group

EXPERIMENTAL

6 mg/d Astaxanthin (Haematococcus pluvialis)

Dietary Supplement: Low-Dose AST

High-Dose AST Group

EXPERIMENTAL

12 mg/d Astaxanthin (Haematococcus pluvialis)

Dietary Supplement: High-Dose AST

Interventions

Low-Dose AST DIETARY_SUPPLEMENT

Low-Dose AST Group:6 mg/d Astaxanthin (Haematococcus pluvialis)

Low-Dose AST Group

High-Dose AST DIETARY_SUPPLEMENT

High-Dose Group: 12 mg/d Astaxanthin (Haematococcus pluvialis)

High-Dose AST Group

Placebo OTHER

Placebo

Placebo Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cognitive functionally normal elderly individuals aged 50 years or older with baseline MoCA scores near the borderline for mild cognitive impairment (MCI); subjects reporting age-related forgetfulness; community-dwelling residents who can cooperate with the research team to complete the intervention study.

You may not qualify if:

• Individuals with hearing or language expression impairments that hinder communication; those with severe cardiovascular, cerebrovascular, hepatic, renal, or other organ diseases, or malignant tumors; individuals who have been taking astaxanthin or other antioxidant dietary supplements within the past month; those who have recently used medications that may affect neurological function; and individuals who are unable to undergo cognitive function assessment or refuse to sign an informed consent form.

Sponsors & Collaborators

• Capital Medical University: lead

Study Officials

• Linhong Yuan, Doctor

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Miao

CONTACT

+86 13261666004; miaochen0243@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share