NCT07379437

Haematococcus Pluvialis Astaxanthin for Brain Aging

Effects and Mechanism of Haematococcus Pluvialis Astaxanthin on Inhibiting Brain Aging Through Improving Mitochondrial Function

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study proposed to set the intervention doses at 6 mg/day and 12 mg/day, with an intervention period of 6 months. The intervention agent was Astaxanthin Capsules from Haematococcus pluvialis (containing 6 mg of astaxanthin per capsule) supplied by Astareal Corporation, Japan. The control group received placebo capsules identical to the intervention group in terms of color, shape, size, packaging, and quantity but devoid of astaxanthin. Prior to the experiment, random sampling was conducted on the intervention capsules to verify the effective content of astaxanthin, ensuring the accuracy of the intervention doses. During the intervention period, experimenters distributed the intervention and control capsules to the corresponding populations, along with a consumption record form. The dosage for each month was administered, and the capsule containers were collected at the end of each month. Daily text messages were sent to remind participants to take the capsules and check in, with compliance assessed based on the record form and check-in records.A self-designed questionnaire was used to conduct baseline surveys on the study subjects, covering demographic characteristics, lifestyle, and medical history. The demographic survey included gender, age, educational level, marital status, occupation, and housing conditions. Lifestyle factors were assessed through smoking, alcohol consumption, mental activity (e.g., reading, newspaper consumption, computer use, television viewing), physical activity, household chores, and dietary supplement use. Past medical history encompassed current illnesses, prior diseases, family genetic history, duration of illness, and medication regimens. Physical examinations were performed by community health center physicians, measuring routine parameters such as height, weight, waist circumference, and blood pressure, with calculation of body mass index (BMI).The dietary questionnaire designed by the research team was administered through face-to-face interviews by specially trained investigators.Cognitive function was measured before intervention (baseline), at 3 months of intervention, and at the end of intervention (6 months of intervention), including the following tests: 1) Tracking the changes in the brain's neural electrophysiology during cognitive processes using event-related potential (ERP) P300.2) The Montreal Cognitive Assessment (MoCA) was used to evaluate the cognitive function of the subjects.The Siemens Trio 3T MRI system was used to acquire imaging data, including T1-weighted structural and resting-state functional scans as well as T2w-FLAIR images.Fasting peripheral blood samples were collected at three time points (pre-intervention, 3 months, and 6 months), and after processing, underwent comprehensive laboratory analyses including routine metabolic panels, plasma astaxanthin, mitochondrial function, oxidative stress markers, and cognition-related neurobiomarkers.

Conditions

• Brain Aging

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low-Dose AST	Low-Dose AST Group:6 mg/d Astaxanthin (Haematococcus pluvialis)
DIETARY_SUPPLEMENT	High-Dose AST	High-Dose Group: 12 mg/d Astaxanthin (Haematococcus pluvialis)
OTHER	Placebo	Placebo

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2026-01-30
• Last updated: 2026-01-30