Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT06432868
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
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT06432868
Study Brief:
Protocol Section:
NCT06432868