NCT05282355

Brief Summary

Briefly, this study involved 2 trials: baseline (Trial 1) and post-astaxanthin intervention (Trial 2). Both trials included participants completing a graded exercise test while connected to a metabolic cart, to measure cardiorespiratory measures. Between trials, participants were supplemented with either 12 mg of astaxanthin or placebo for 4 weeks. It was hypothesized astaxanthin supplementation would increase rates of fat oxidation, while decreasing carbohydrate oxidation and blood lactate accumulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

February 21, 2022

Last Update Submit

March 7, 2022

Conditions

Keywords

substrate oxidationlactatesupplement

Outcome Measures

Primary Outcomes (1)

  • Changes to substrate oxidation rates

    Substrate oxidation rates reflect cellular utilization of carbohydrates and lipids at rest and during exercise. If changes exist from astaxanthin supplementation, they would manifest themselves likely via increases to rates of fat oxidation at all stages and a subsequent decrease in carbohydrate oxidation rates at each stage.

    Up to 4 weeks

Study Arms (2)

Astaxanthin

EXPERIMENTAL

The astaxanthin group received 12 mg/day of astaxanthin. Each capsule contained 6 mg of astaxanthin and sunflower oil, and each subject ingested one capsule in the morning and one in the evening.

Dietary Supplement: Astaxanthin

Placebo

PLACEBO COMPARATOR

The placebo group ingested two capsules per day, one in the morning and one in the evening. Each capsule contained sunflower oil and mimicked the size and appearance of the astaxanthin supplement.

Dietary Supplement: Placebo

Interventions

AstaxanthinDIETARY_SUPPLEMENT

Our aim was to examine the impact astaxanthin would have, if any, on markers of metabolic flexibility in overweight individuals in comparison to a placebo.

Astaxanthin
PlaceboDIETARY_SUPPLEMENT

To have adequately test the effects of astaxanthin, we provided one group a placebo matched in appearance and taste.

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Free of any cardiometabolic disease medication
  • Classified as overweight - body fat % ≥ 20% (M) and ≥ 25% (F)
  • Exclude dietary supplements for 2 weeks prior to start of study

You may not qualify if:

  • If there is a chance of pregnancy
  • body fat % \< 20% (M) and \< 25% (F)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Alabama, Department of Kinesiology

Florence, Alabama, 35630, United States

Location

MeSH Terms

Interventions

astaxanthine

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants were blinded to either the supplement or placebo. The capsules were identical in appearance and size. Blinding was accomplished via an investigator not directly involved with data collection.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 16, 2022

Study Start

May 12, 2021

Primary Completion

July 2, 2021

Study Completion

July 2, 2021

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Unless required, we do not plan on sharing our subjects data, even though the data is coded. Since this study is being registered post-completion, we did not make our subjects aware their data may be shared outside of our research team and therefore, we find this a potential conflict of ethical consideration for our subjects.

Locations