Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511960
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Effects of Astaxanthin Supplementation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Four Weeks of Astaxanthin Supplementation at Varied Doses on Muscle Pain Muscle Damage Markers and Total Antioxidant Status in Exercising Males A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Astaxanthin is a potent antioxidant and anti-inflammatory carotenoid Research examining whether astaxanthin AX could counteract exercise-induced muscle damage and improve exercise capacity reported inconsistent resultsTherefore the aim of this study was to explore the impact of 4 weeks supplementation with AX on muscle damage markers total antioxidant status and subjective marker of muscle pain Twenty-four males were randomly assigned to the AX12 group 12 mgday n8 AX36 group 36 mgday n9 or placebo group PLC n7 After 4 weeks of supplementation blood samples were collected at rest immediately after and at 2 24 48 and 72 hours following eccentric arm exercise at 85 of predetermined one repetition maximum to assess muscle damage markers creatine kinase and lactate dehydrogenase total antioxidant status malondialdehyde and uric acid and muscle pain levels were evaluated using the Numerical Visual Pain Scale0-10
Detailed Description:
This study followed a placebo-controlled double-blind participants and co-researcher administering the supplementation and three-group parallel design to examine the effects of an AX supplement on muscle pain muscle damage markers and total antioxidant status TAS
Participants reported to the laboratory on 2 separate occasions one initial session to measure anthropometrics and 1-repetition maximum 1RM strength of the arm muscles and as well as to collect resting venous blood samples prior to the four-week supplementation period Upon arrival at the laboratory for their initial visits each participant underwent measurements of body mass MC 780 ST Black and body height Telescopic Height Meter after which resting venous blood samples were collected from the median antecubital vein by a healthcare professional
Following these baseline measurements participants were assigned to one of the groups through a strict randomization process which included selecting boxes numbered up to 24 all with the same size color and pattern Participants were asked to choose one of the random numbers accompanied by an independent person other than the researchers This process was recorded by the supervisor in paper-based surveys and digitally Subsequently all participants were instructed to consume their corresponding supplements 4 mgday AX 12 mgday AX or 12 mgday PLC for 4 weeks
After the 4 weeks of supplementation participants reported to the laboratory for the post-supplementation measurements that included the collection of blood samples at rest immediately after as well as at 2 24 48 and 72 hours following completing eccentric arm exercises performed at 85 of predetermined 1RM
Before obtaining blood samples ie immediately after and at 2 24 48 and 72 hours after exercises participants were asked to assess their current pain levels using the Numerical Visual Pain Scale NRS ranging between 0-10 and 0-100 to determine any correspondence with muscle damage markers in the blood 25
All participants were instructed to abstain from taking any medications for a minimum of 7 days prior to the study and to avoid consuming vitamins foods or supplements containing antioxidants as well as analgesics aspirin or any other anti-inflammatory drugs throughout the duration of the study A list of AX-rich foods beverages and vitamins was provided to each participant prior to testing and all participants were asked to avoid these items during both 4-week supplementation periods and to maintain their regular eating habits and refrain from strenuous exercise to minimize the risk of muscle damage A WhatsApp group was created for the purpose of monitoring the participants supplement use
To ascertain the extent of product usage a survey form created using Google Forms was disseminated during the supplementation period Participants were required to approve the form on a daily basis At the end of each day the data entered into the Excel file created using OneDrive was reviewed by at least one researcher
Participants reported to the laboratory on 2 separate occasions one initial session to measure anthropometrics and 1-repetition maximum 1RM strength of the arm muscles and as well as to collect resting venous blood samples prior to the four-week supplementation period Upon arrival at the laboratory for their initial visits each participant underwent measurements of body mass MC 780 ST Black and body height Telescopic Height Meter after which resting venous blood samples were collected from the median antecubital vein by a healthcare professional
Following these baseline measurements participants were assigned to one of the groups through a strict randomization process which included selecting boxes numbered up to 24 all with the same size color and pattern Participants were asked to choose one of the random numbers accompanied by an independent person other than the researchers This process was recorded by the supervisor in paper-based surveys and digitally Subsequently all participants were instructed to consume their corresponding supplements 4 mgday AX 12 mgday AX or 12 mgday PLC for 4 weeks
After the 4 weeks of supplementation participants reported to the laboratory for the post-supplementation measurements that included the collection of blood samples at rest immediately after as well as at 2 24 48 and 72 hours following completing eccentric arm exercises performed at 85 of predetermined 1RM
Before obtaining blood samples ie immediately after and at 2 24 48 and 72 hours after exercises participants were asked to assess their current pain levels using the Numerical Visual Pain Scale NRS ranging between 0-10 and 0-100 to determine any correspondence with muscle damage markers in the blood 25
All participants were instructed to abstain from taking any medications for a minimum of 7 days prior to the study and to avoid consuming vitamins foods or supplements containing antioxidants as well as analgesics aspirin or any other anti-inflammatory drugs throughout the duration of the study A list of AX-rich foods beverages and vitamins was provided to each participant prior to testing and all participants were asked to avoid these items during both 4-week supplementation periods and to maintain their regular eating habits and refrain from strenuous exercise to minimize the risk of muscle damage A WhatsApp group was created for the purpose of monitoring the participants supplement use
To ascertain the extent of product usage a survey form created using Google Forms was disseminated during the supplementation period Participants were required to approve the form on a daily basis At the end of each day the data entered into the Excel file created using OneDrive was reviewed by at least one researcher
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None