## Protocol Section
### Identification Module
**NCT ID:** NCT06432868

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 927
#### Organization
**Class:** OTHER
**Full Name:** Kent State University
### Status Module
#### Completion Date
**Date:** 2025-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-17

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kent State University

#### Responsible Party

**Investigator Affiliation:** Kent State University

**Investigator Full Name:** Adam Jajtner

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Muscle Damage

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 46

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Dietary Supplement: Solarplast (R)

**Label:** Solarplast (R)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Dietary Supplement: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Solarplast (R)

**Description:** Daily supplementation for 28 days prior to heavy resistance exercise.

**Name:** Solarplast (R)

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Daily supplementation for 28 days prior to heavy resistance exercise.

**Name:** Placebo

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Other Outcomes

**Description:** Measure of Performance Change

**Measure:** Rate of Muscular Fatigue

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Measure of Performance Change

**Measure:** Rate of Muscular Fatigue

**Time Frame:** Change in Resting Values over 4 weeks of supplementation

**Description:** Marker of Muscle Damage

**Measure:** Lactate Dehydrogenase Activity

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Circulating Marker of Stress

**Measure:** Cortisol Concentration

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Circulating Marker of Stress

**Measure:** Cortisol Concentration

**Time Frame:** Change in Resting Values over 4 weeks of supplementation

**Description:** Circulating Marker of Oxidative Stress

**Measure:** Glutathione (GSH) Activity

**Time Frame:** Change in Resting Values over 4 weeks of supplementation

**Description:** Circulating Marker of Oxidative Stress

**Measure:** Glutathione (GSH) Activity

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Circulating Marker of Oxidative Stress

**Measure:** Total Antioxidant Capacity

**Time Frame:** Change in Resting Values over 4 weeks of supplementation

**Description:** Circulating Marker of Oxidative Stress

**Measure:** Total Antioxidant Capacity

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Circulating Marker of Inflammation

**Measure:** Interleukin 6 (IL-6) Concentration

**Time Frame:** Change in Resting Values over 4 weeks of supplementation

**Description:** Circulating Marker of Inflammation

**Measure:** Interleukin 6 (IL-6) Concentration

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Circulating Marker of Inflammation

**Measure:** Interleukin 10 (IL-10) Concentration

**Time Frame:** Change in Resting Values over 4 weeks of supplementation

**Description:** Circulating Marker of Inflammation

**Measure:** Interleukin 10 (IL-10) Concentration

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Circulating Marker of Inflammation

**Measure:** Tumor Necrosis Factor - alpha (TNFa) Concentration

**Time Frame:** Change in Resting Values over 4 weeks of supplementation

**Description:** Circulating Marker of Inflammation

**Measure:** Tumor Necrosis Factor - alpha (TNFa) Concentration

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Measure of Performance Change

**Measure:** Rate of Force Development

**Time Frame:** Change in Resting Values over 4 weeks of supplementation

**Description:** Measure of Performance Change

**Measure:** Peak Muscle Force

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Measure of Performance Change

**Measure:** Vertical Jump Height

**Time Frame:** Change in Resting Values over 4 weeks of supplementation

#### Primary Outcomes

**Description:** Marker of Muscle Damage

**Measure:** Creatine Kinase Activity

**Time Frame:** Acute changes following exercise for 48 hours

#### Secondary Outcomes

**Description:** Marker of Muscle Damage

**Measure:** Myoglobin Concentration

**Time Frame:** Acute changes following exercise for 24 hours

**Description:** Measure of Performance Change

**Measure:** Vertical Jump Height

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Measure of Performance Change

**Measure:** Mean Squat Velocity

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Measure of Performance Change

**Measure:** Peak Isometric Muscle Force

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Measure of Performance Change

**Measure:** Rate of Force Development

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Visual Analog Scale (1-100mm; low values indicate reduced soreness)

**Measure:** Ratings of Perceived Soreness

**Time Frame:** Acute changes following exercise for 48 hours

**Description:** Visual Analog Scale (1-100mm; low values indicated reduced fatigue)

**Measure:** Ratings of Perceived Fatigue

**Time Frame:** Acute changes following exercise for 48 hours

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ajajtner@kent.edu

**Name:** Adam R Jajtner, PhD

**Phone:** 330-672-0212

**Phone Ext:** 20212

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Kent

**Contacts:**

***Contact 1:***

- **Email:** ajajtner@kent.edu

- **Name:** Adam R Jajtner, PhD

- **Phone:** 330-672-0212

- **Phone Ext:** 20212

- **Role:** CONTACT

**Country:** United States

**Facility:** Kent State University - Exercise Science & Exercise Physiology

**State:** Ohio

**Status:** RECRUITING

**Zip:** 44242

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
