Astaxanthin, Exercise Inflammation, Skin Health

NCT05409092 | Completed

• 1 other identifier: 22-0100
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Vigorous exercise can stress the body. Consuming special types of diet supplements may help the body recover better from exercise. This includes a bright red supplement called astaxanthin that is found in certain algae and causes the pink-red color in salmon. Astaxanthin is an antioxidant and may protect cells from damage and improve the way the immune system functions. The main purpose of this study is to determine if 4 weeks of consuming astaxanthin improves recovery from 2.25 hours of intensive running on a treadmill. This study will also measure whether or not astaxanthin supplementation improves skin health

Conditions

Inflammatory Response; Metabolic Disturbance; Immune Suppression

Keywords

astaxanthin; exercise; immune function; proteomics; cytokines; muscle damage

Outcome Measures

Primary Outcomes (1)

• Plasma lipid mediators

  Plasma concentrations of arachadonic acid oxidized derivatives from LC-MS-MS analysis

  Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exerciseingestion to 8- and 24-hours post-ingestion

Secondary Outcomes (2)

• Plasma proteins

  Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exerciseingestion to 8- and 24-hours post-ingestion

• Plasma cytokine panel

  Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exerciseingestion to 8- and 24-hours post-ingestion

Study Arms (2)

Astaxanthin

EXPERIMENTAL

The astaxanthin capsules will contain 8 mg of astaxanthin from freshwater algae in starch beadlets. Ingested daily for 4 weeks.

Dietary Supplement: Astaxanthin

Placebo

PLACEBO COMPARATOR

The placebo capsules will contain just the starch beadlets with natural red coloring from the pitaya fruit. Ingested daily for 4 weeks.

Dietary Supplement: Placebo

Interventions

Astaxanthin DIETARY_SUPPLEMENT

8 mg/day in one capsule for 4 weeks

Astaxanthin

Placebo DIETARY_SUPPLEMENT

8 mg/day in one capsule for 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 57 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, ages 18-57 years.
• Non-smoker.
• Capable of running 2.25 h on laboratory treadmills at 70% VO2max (close to marathon race pace).
• Agree to train normally, maintain weight, and avoid the regular use of large-dose vitamin and mineral supplements, herbs, and medications that influence inflammation and immune function (especially Advil, Motrin, aspirin, and similar anti-inflammatory drugs) for the duration of the 10-week study. (Review supplement and medication use with the Research Manager during orientation).
• Agree to taper exercise training prior to each of the two lab running sessions (as if preparing for a race).
• Willing to avoid astaxanthin supplements (other than what is provided) and natural sources of astaxanthin including algae, yeast, salmon, trout, krill, shrimp and crayfish during the 10-week study.
• Categorized as "low risk" using the American College of Sports Medicine screening questionnaire.
• Generally healthy and without chronic disease including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 and 2 diabetes, rheumatoid arthritis.

You may not qualify if:

• Inability to comply with study requirements.
• Body weight below 110 pounds.
• Pregnant or breastfeeding.
• Any other concurrent condition which, in the opinion of the primary investigator (PI), would preclude participation in this study or interfere with compliance.
• Current diagnosis of cardiovascular disease, diabetes, or cancer (except for non-melanoma skin cancer).
• History of allergic reactions to astaxanthin.
• Using drugs with 5-alpha-reductase inhibitor (Proscar, Propecia, Avodart, Jalyn).

Sponsors & Collaborators

• Appalachian State University: lead
• LycoRed Ltd.: collaborator

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• David C Nieman, DrPH

  Appalachian State Univ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigators and study participants will be blind to treatment allocation, with the astaxanthin and placebo supplements contained in identical looking capsules.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized treatment, double blinded procedures, crossover

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 8, 2022
• Study Start: January 19, 2022
• Primary Completion: July 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: September 2022; indefinitely
• Access Criteria: Upon request

Locations

US (1)