Recruiting

Solarplast

Sponsor:

Kent State University

Code:

NCT06432868

Conditions

Muscle Damage

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Solarplast (R)

Placebo

Study Details

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.

Conditions

Muscle Damage

Study ID

NCT06432868

Start date

Apr 17, 2024

Status verified date

May, 2024

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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 Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Solarplast (R)

100mg/day of Solarplast (R) supplementation (28 days).

placebo comparator: Placebo

100mg/day of Placebo (maltodextrin (98.8%) and medium chain triglycerides (1.2%)).

Interventions

Solarplast (R)

Daily supplementation for 28 days prior to heavy resistance exercise.

Placebo

Daily supplementation for 28 days prior to heavy resistance exercise.

Primary outcome measure

  • Creatine Kinase Activity [ Time Frame: Acute changes following exercise for 48 hours ]

Central Contacts and Locations

Central contacts

Locations

Kent State University - Exercise Science & Exercise Physiology

Recruiting

Kent, Ohio, United States, 44242

Contacts

More Information

Sponsor

Kent State University

Last update posted

May 29, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kent State University on 2024-05-29.