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

NCT ID: NCT06432868

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2025-03-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Solarplast (R)

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

Group Type: ACTIVE_COMPARATOR

Solarplast (R)

Intervention Type: DIETARY_SUPPLEMENT

Daily supplementation for 28 days prior to heavy resistance exercise.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Daily supplementation for 28 days prior to heavy resistance exercise.

Interventions

Solarplast (R)

Daily supplementation for 28 days prior to heavy resistance exercise.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Daily supplementation for 28 days prior to heavy resistance exercise.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kent State University

OTHER

Sponsor Role: lead

Responsible Party

Adam Jajtner

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kent State University - Exercise Science & Exercise Physiology

Kent, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Adam R Jajtner, PhD

Role: CONTACT

ajajtner@kent.edu

330-672-0212 ext. 20212

Facility Contacts

Adam R Jajtner, PhD

Role: primary

ajajtner@kent.edu

330-672-0212 ext. 20212

Other Identifiers

927

Identifier Type: -

Identifier Source: org_study_id