Impact of Astaxanthin on Cognition in Recreationally Active Females

NCT06460181 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2024-021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the protentional that the antioxidant Astaxanthin has on mitigating cognitive decline following mental fatigue.

Conditions

Mental Fatigue

Outcome Measures

Primary Outcomes (4)

• Reaction time

  How quickly the participant reacts to a stimulus. Expressed in millaseconds.

  Pre supplementation and post 4-week supplementation period.

• Speed

  Speed at which responses are given.

  Pre supplementation and post 4-week supplementation period.

• Responses Correct per Second

  Accuracy of responses over time.

  Pre supplementation and post 4-week supplementation period.

• Mental Fatigue

  Assessed using a 180mm visual analog scale. 0mm = no mental fatigue, 180mm = highest possible mental fatigue.

  Pre supplementation and post 4-week supplementation period.

Secondary Outcomes (1)

• Lipid Panel

  Pre and post

Study Arms (2)

Astaxanthin

ACTIVE COMPARATOR

Astaxanthin will be administered in a dosage of 12 mg/day orally by one soft gel capsule per day. the capsule consist of natural Astaxanthin and olive oil.

Dietary Supplement: Astaxanthin

Placebo

PLACEBO COMPARATOR

The placebo will be administered orally by one soft gel capsule per day. The placebo contains olive oil and is color, order, and taste matched to the Astaxanthin soft gels.

Dietary Supplement: Placebo

Interventions

Astaxanthin DIETARY_SUPPLEMENT

Manufactured by AstaReal Inc

Astaxanthin

Placebo DIETARY_SUPPLEMENT

Manufactured by AstaReal Inc

Placebo

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The participant population will be healthy, recreationally active females between the ages of 18-39 without any medical conditions. To be deemed recreationally active, they must meet the World Health Organization minimum activity guidelines of completing at least 150 to 300 min moderate-intensity activity or 75-150 min of vigorous-intensity activity a week, plus muscle-strengthening activities 2 or more days a week.
• Adult females with a stable body weight (± 5 lbs.) for 2 months
• Adult females with a normal menstrual cycle
• Adult females not on a low-carb, high-fat diet or intermittent fasting
• Adult females who are not pregnant of actively attempting to become pregnant

Sponsors & Collaborators

• University of North Alabama: lead

Study Sites (1)

University of North Alabama

Florence, Alabama, 35632, United States

RECRUITING

MeSH Terms

Conditions

Mental Fatigue

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Central Study Contacts

Gaven A Barker

CONTACT

678-699-3248; gbarker@una.edu

Hunter S Waldman

CONTACT

256-765-4996; hswaldman@una.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will supplement with either AX or a matched placebo. The dosage of AX (12 mg/day) is FDA approved and will be administered orally by one soft gel capsule. The treatments will be blinded to the participants and the investigator. Treatments will be sorted be an independent party not associated with data collection or analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Groups will be randomized and parallel. They will not cross-over with each other.

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 14, 2024
• Study Start: August 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)