Clinical trial NCT06432868: Solarplast (R) Supplementation Effects Following High-intensity Resistance Exercise
Official title: Effects of Solarplast (R) Supplementation on Biomarkers of Muscle Damage, Inflammation and Recovery of Physical Performance Following High-intensity Resistance Exercise
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscle Damage
Lead sponsor: Kent State University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Creatine Kinase Activity
timeFrame: Acute changes following exercise for 48 hours
Secondary outcomes:
measure: Myoglobin Concentration
timeFrame: Acute changes following exercise for 24 hours
measure: Vertical Jump Height
timeFrame: Acute changes following exercise for 48 hours
measure: Mean Squat Velocity
timeFrame: Acute changes following exercise for 48 hours
measure: Peak Isometric Muscle Force
timeFrame: Acute changes following exercise for 48 hours
measure: Rate of Force Development
timeFrame: Acute changes following exercise for 48 hours
measure: Ratings of Perceived Soreness
timeFrame: Acute changes following exercise for 48 hours
measure: Ratings of Perceived Fatigue
timeFrame: Acute changes following exercise for 48 hours
Other outcomes:
measure: Rate of Muscular Fatigue
timeFrame: Acute changes following exercise for 48 hours
measure: Rate of Muscular Fatigue
timeFrame: Change in Resting Values over 4 weeks of supplementation
measure: Lactate Dehydrogenase Activity
timeFrame: Acute changes following exercise for 48 hours
measure: Cortisol Concentration
timeFrame: Acute changes following exercise for 48 hours
measure: Cortisol Concentration
timeFrame: Change in Resting Values over 4 weeks of supplementation
measure: Glutathione (GSH) Activity
timeFrame: Change in Resting Values over 4 weeks of supplementation
measure: Glutathione (GSH) Activity
timeFrame: Acute changes following exercise for 48 hours
measure: Total Antioxidant Capacity
timeFrame: Change in Resting Values over 4 weeks of supplementation
measure: Total Antioxidant Capacity
timeFrame: Acute changes following exercise for 48 hours
measure: Interleukin 6 (IL-6) Concentration
timeFrame: Change in Resting Values over 4 weeks of supplementation
measure: Interleukin 6 (IL-6) Concentration
timeFrame: Acute changes following exercise for 48 hours
measure: Interleukin 10 (IL-10) Concentration
timeFrame: Change in Resting Values over 4 weeks of supplementation
measure: Interleukin 10 (IL-10) Concentration
timeFrame: Acute changes following exercise for 48 hours
measure: Tumor Necrosis Factor - alpha (TNFa) Concentration
timeFrame: Change in Resting Values over 4 weeks of supplementation
measure: Tumor Necrosis Factor - alpha (TNFa) Concentration
timeFrame: Acute changes following exercise for 48 hours
measure: Rate of Force Development
timeFrame: Change in Resting Values over 4 weeks of supplementation
measure: Peak Muscle Force
timeFrame: Acute changes following exercise for 48 hours
measure: Vertical Jump Height
timeFrame: Change in Resting Values over 4 weeks of supplementation
Locations:
city: Kent
country: United States
facility: Kent State University - Exercise Science & Exercise Physiology
state: Ohio
Study officials:
References: