Condition: Healthy Subjects With Low Energy Levels · Sponsor: Applied Food Sciences Inc.
This study is a double-blind, randomized, parallel group, three-arm, placebo-controlled trial of seventy-five (75) apparently healthy male and female participants to be recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences). The study will assess the potential benefits of four weeks of supplementation with 300 mg Ginseng or 1 gram Cordyceps Militaris (vs. placebo). Participants will attend 3 study visits. During Visit 1, participants will be screened for participation (i.e., medical history, routine blood work, background baseline diet and familiarization protocol will be completed). During Visit 2 (Day 0) and Visit 3 (Day 30) participants will complete subjective baseline testing including questionnaires that assess recovery, mood, energy, fatigue, and quality of life. They will complete a VO2 max test, a TTE test, isometric mid-thigh pull, and have their handgrip strength assessed. They will also be tested for changes in circulating nitrates/nitrites (NOx), circulatory efficiency (oxygen pulse), and lactate kinetics (production and clearance). Comprehensive side effect profile/ adverse event monitoring will take place throughout thevstudy duration. The study will be conducted following ICH-GCP guidelines to ensure subject safety and scientific integrity of the data.
This description comes directly from the study's public registry record.
Michael Michael La Monica, Ph.D., CSCS · 330.926.6927 · ml@appliedhealthsciences.org
Tim N Ziegenfuss, PhD, CSCS, FISSN · 330.926.6927 · tz@appliedhealthsciences.org
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| The Center for Applied Health Sciences | Canfield, Ohio, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07729943