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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Muscle Damage
• Intervention / Treatment: Dietary supplement: Solarplast (R); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam R Jajtner, PhD; Phone Number: 20212 330-672-0212; Email: ajajtner@kent.edu

Study Locations

• United States
  • Ohio
    • Kent, Ohio, United States, 44242
      • Recruiting
      • Kent State University - Exercise Science & Exercise Physiology
      • Contact: Adam R Jajtner, PhD; Phone Number: 20212 330-672-0212; Email: ajajtner@kent.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Solarplast (R); 100mg/day of Solarplast (R) supplementation (28 days).	Dietary supplement: Solarplast (R); Daily supplementation for 28 days prior to heavy resistance exercise.
Placebo Comparator: Placebo; 100mg/day of Placebo (maltodextrin (98.8%) and medium chain triglycerides (1.2%)).	Dietary supplement: Placebo; Daily supplementation for 28 days prior to heavy resistance exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creatine Kinase Activity	Marker of Muscle Damage	Acute changes following exercise for 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myoglobin Concentration	Marker of Muscle Damage	Acute changes following exercise for 24 hours
Vertical Jump Height	Measure of Performance Change	Acute changes following exercise for 48 hours
Mean Squat Velocity	Measure of Performance Change	Acute changes following exercise for 48 hours
Peak Isometric Muscle Force	Measure of Performance Change	Acute changes following exercise for 48 hours
Rate of Force Development	Measure of Performance Change	Acute changes following exercise for 48 hours
Ratings of Perceived Soreness	Visual Analog Scale (1-100mm; low values indicate reduced soreness)	Acute changes following exercise for 48 hours
Ratings of Perceived Fatigue	Visual Analog Scale (1-100mm; low values indicated reduced fatigue)	Acute changes following exercise for 48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Muscular Fatigue	Measure of Performance Change	Acute changes following exercise for 48 hours
Rate of Muscular Fatigue	Measure of Performance Change	Change in Resting Values over 4 weeks of supplementation
Lactate Dehydrogenase Activity	Marker of Muscle Damage	Acute changes following exercise for 48 hours
Cortisol Concentration	Circulating Marker of Stress	Acute changes following exercise for 48 hours
Cortisol Concentration	Circulating Marker of Stress	Change in Resting Values over 4 weeks of supplementation
Glutathione (GSH) Activity	Circulating Marker of Oxidative Stress	Change in Resting Values over 4 weeks of supplementation
Glutathione (GSH) Activity	Circulating Marker of Oxidative Stress	Acute changes following exercise for 48 hours
Total Antioxidant Capacity	Circulating Marker of Oxidative Stress	Change in Resting Values over 4 weeks of supplementation
Total Antioxidant Capacity	Circulating Marker of Oxidative Stress	Acute changes following exercise for 48 hours
Interleukin 6 (IL-6) Concentration	Circulating Marker of Inflammation	Change in Resting Values over 4 weeks of supplementation
Interleukin 6 (IL-6) Concentration	Circulating Marker of Inflammation	Acute changes following exercise for 48 hours
Interleukin 10 (IL-10) Concentration	Circulating Marker of Inflammation	Change in Resting Values over 4 weeks of supplementation
Interleukin 10 (IL-10) Concentration	Circulating Marker of Inflammation	Acute changes following exercise for 48 hours
Tumor Necrosis Factor - alpha (TNFa) Concentration	Circulating Marker of Inflammation	Change in Resting Values over 4 weeks of supplementation
Tumor Necrosis Factor - alpha (TNFa) Concentration	Circulating Marker of Inflammation	Acute changes following exercise for 48 hours
Rate of Force Development	Measure of Performance Change	Change in Resting Values over 4 weeks of supplementation
Peak Muscle Force	Measure of Performance Change	Acute changes following exercise for 48 hours
Vertical Jump Height	Measure of Performance Change	Change in Resting Values over 4 weeks of supplementation

Collaborators and Investigators

• Sponsor: Kent State University

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 927

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No