Solarplast (R) Supplementation Effects Following High-intensity Resistance Exercise

Muscle Damage Clinical Trial

Official title:

Effects of Solarplast (R) Supplementation on Biomarkers of Muscle Damage, Inflammation and Recovery of Physical Performance Following High-intensity Resistance Exercise

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06432868
• Other study ID #: 927
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: Kent State University
• Contact: Adam R Jajtner, PhD
• Phone: 330-672-0212
• Email: ajajtner[@]kent.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary goal of this investigation is to assess whether Solarplast (R) supplementation will improve recovery following heavy resistance exercise in active adults. The primary questions to be addressed are: Does Solarplast (R) decrease muscle damage and inflammation associated with heavy resistance exercise? Does Solarplast (R) reduce the decline in performance associate with heavy resistance exercise? Researchers will compare Solarplast (R) to a placebo (a look-alike substance that contains no active ingredients) to see if Solarplast (R) is effective at improving recovery. Participants will be asked to: Take Solarplast (R) or placebo daily for 4 weeks Visit the laboratory at least once per week to receive their supplement Report to the lab for 3 consecutive visits following supplementation to complete a heavy resistance training session and follow-up testing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Recreationally-active (participated in at least 2 weight training workouts per week over the previous year) and participates in at least 3h of total structured exercise/week as determined by the health and activity questionnaire.
• Subject is judged by the Investigator to be healthy and free of any physical limitations (determined by health and activity questionnaire)
• Subject has a body mass index of 18.0-34.9 kg/m2, inclusive
• Subject is willing to maintain habitual diet throughout the study period
• Subject is willing to abstain from dietary supplementation throughout the duration of the study.
• Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators

Exclusion Criteria:

• Subject is currently or will be enrolled in another clinical trial.
• Subject is a habitual consumer of tea/antioxidants defined as > 8 oz/day of either green or black tea within the 14 days prior to the screening visit.
• Subject has a history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.
• Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• Subject is unable to perform physical exercise (determined by health and activity questionnaire)
• Subject is engaged in an extreme diet including but not limited to, Atkins, South Beach, Intermittent Fasting, etc.
• Subject is allergic to the study product or placebo
• Subject is taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire)
• Subject has any chronic illness that causes continuous medical care
• Taking any type of prescription or over-the-counter medication including but not limited to corticosteroids, non-steroidal anti-inflammatory drugs, and antibiotics within the 14 days prior to the screening visit.

Related Conditions & MeSH terms

• Muscle Damage

Intervention

Dietary Supplement:
• Solarplast (R)
Daily supplementation for 28 days prior to heavy resistance exercise.
• Placebo
Daily supplementation for 28 days prior to heavy resistance exercise.

Locations

Country	Name	City	State
United States	Kent State University - Exercise Science & Exercise Physiology	Kent	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Kent State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of Muscular Fatigue	Measure of Performance Change	Acute changes following exercise for 48 hours
Other	Rate of Muscular Fatigue	Measure of Performance Change	Change in Resting Values over 4 weeks of supplementation
Other	Lactate Dehydrogenase Activity	Marker of Muscle Damage	Acute changes following exercise for 48 hours
Other	Cortisol Concentration	Circulating Marker of Stress	Acute changes following exercise for 48 hours
Other	Cortisol Concentration	Circulating Marker of Stress	Change in Resting Values over 4 weeks of supplementation
Other	Glutathione (GSH) Activity	Circulating Marker of Oxidative Stress	Change in Resting Values over 4 weeks of supplementation
Other	Glutathione (GSH) Activity	Circulating Marker of Oxidative Stress	Acute changes following exercise for 48 hours
Other	Total Antioxidant Capacity	Circulating Marker of Oxidative Stress	Change in Resting Values over 4 weeks of supplementation
Other	Total Antioxidant Capacity	Circulating Marker of Oxidative Stress	Acute changes following exercise for 48 hours
Other	Interleukin 6 (IL-6) Concentration	Circulating Marker of Inflammation	Change in Resting Values over 4 weeks of supplementation
Other	Interleukin 6 (IL-6) Concentration	Circulating Marker of Inflammation	Acute changes following exercise for 48 hours
Other	Interleukin 10 (IL-10) Concentration	Circulating Marker of Inflammation	Change in Resting Values over 4 weeks of supplementation
Other	Interleukin 10 (IL-10) Concentration	Circulating Marker of Inflammation	Acute changes following exercise for 48 hours
Other	Tumor Necrosis Factor - alpha (TNFa) Concentration	Circulating Marker of Inflammation	Change in Resting Values over 4 weeks of supplementation
Other	Tumor Necrosis Factor - alpha (TNFa) Concentration	Circulating Marker of Inflammation	Acute changes following exercise for 48 hours
Other	Rate of Force Development	Measure of Performance Change	Change in Resting Values over 4 weeks of supplementation
Other	Peak Muscle Force	Measure of Performance Change	Acute changes following exercise for 48 hours
Other	Vertical Jump Height	Measure of Performance Change	Change in Resting Values over 4 weeks of supplementation
Primary	Creatine Kinase Activity	Marker of Muscle Damage	Acute changes following exercise for 48 hours
Secondary	Myoglobin Concentration	Marker of Muscle Damage	Acute changes following exercise for 24 hours
Secondary	Vertical Jump Height	Measure of Performance Change	Acute changes following exercise for 48 hours
Secondary	Mean Squat Velocity	Measure of Performance Change	Acute changes following exercise for 48 hours
Secondary	Peak Isometric Muscle Force	Measure of Performance Change	Acute changes following exercise for 48 hours
Secondary	Rate of Force Development	Measure of Performance Change	Acute changes following exercise for 48 hours
Secondary	Ratings of Perceived Soreness	Visual Analog Scale (1-100mm; low values indicate reduced soreness)	Acute changes following exercise for 48 hours
Secondary	Ratings of Perceived Fatigue	Visual Analog Scale (1-100mm; low values indicated reduced fatigue)	Acute changes following exercise for 48 hours