NCT06432868

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

12 months

First QC Date

April 29, 2024

Last Update Submit

May 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Creatine Kinase Activity

    Marker of Muscle Damage

    Acute changes following exercise for 48 hours

Secondary Outcomes (7)

  • Myoglobin Concentration

    Acute changes following exercise for 24 hours

  • Vertical Jump Height

    Acute changes following exercise for 48 hours

  • Mean Squat Velocity

    Acute changes following exercise for 48 hours

  • Peak Isometric Muscle Force

    Acute changes following exercise for 48 hours

  • Rate of Force Development

    Acute changes following exercise for 48 hours

  • +2 more secondary outcomes

Other Outcomes (18)

  • Rate of Muscular Fatigue

    Acute changes following exercise for 48 hours

  • Rate of Muscular Fatigue

    Change in Resting Values over 4 weeks of supplementation

  • Lactate Dehydrogenase Activity

    Acute changes following exercise for 48 hours

  • +15 more other outcomes

Study Arms (2)

Solarplast (R)

ACTIVE COMPARATOR

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

Dietary Supplement: Solarplast (R)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Solarplast (R)DIETARY_SUPPLEMENT

Daily supplementation for 28 days prior to heavy resistance exercise.

Solarplast (R)
PlaceboDIETARY_SUPPLEMENT

Daily supplementation for 28 days prior to heavy resistance exercise.

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kent State University - Exercise Science & Exercise Physiology

Kent, Ohio, 44242, United States

RECRUITING

Central Study Contacts

Adam R Jajtner, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 29, 2024

Study Start

April 17, 2024

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations