None listed
Conditions
Interventions
Dietary Supplement : The test food is a jelly containing deer antler enzyme-hydrolyzed extract (HENKIV®), administered orally. Subjects consume one packet (20 g, containing 0.48 g of HENKIV®) once dai
all other aspects—formulation, appearance, mechanism, packaging, and dosing schedule—are identical.
Sponsors
Hanyang University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged 18–50 years, male or female 2. Body mass index (BMI) = 18.5 and < 30.0 kg/m². 3. Has received a detailed explanation of the study, voluntarily agrees to participate, and provides written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known allergy or intolerance to the investigational product or its components (e.g., deer-antler–derived ingredients, herbal extracts, excipients). 2. Unable to perform cycle-ergometer CPET or has musculoskeletal/neurological limitations that preclude exercise testing. 3. Participation in vigorous endurance training incompatible with the protocol (e.g., competitive athletes or =4 high-intensity sessions/week in the past 3 months), at the investigator’s judgment. 4. Use within the past 3 months of ergogenic supplements/agents that may affect performance (e.g., high-dose caffeine products, nitrate supplements, creatine loading, beta-alanine) or plans to use them during the study. 5 Current smoker >20 cigarettes/day or unwilling to abstain on test days. 6. Excessive alcohol intake: >280 g/week (men) or >140 g/week (women), or alcohol abuse. 7. Uncontrolled hypertension: SBP =140 mmHg or DBP =90 mmHg, or on newly initiated antihypertensive therapy within 3 months. 8. Diabetes mellitus not controlled (fasting glucose =180 mg/dL) or anti-diabetic medication newly started within 3 months. 9. History or presence of significant cardiovascular, cerebrovascular, respiratory, gastrointestinal, hepatic, renal, endocrine (incl. thyroid), hematologic, or oncologic disease that may increase risk or affect outcomes. 10. Psychiatric disorders (e.g., major depression, anxiety disorders) or use of psychotropic medications judged to affect participation or outcomes. 11. Dyslipidemia requiring drug therapy that is unstable or newly initiated within 3 months. 12. Clinically significant anemia or other hematologic abnormality (Hb 3× ULN; eGFR 2× ULN. 14. Major surgery within the past 6 months or planned surgery during the study. 15. Acute illness, infection, or fever within 7 days prior to key assessments. 16. Pregnant or lactating women; women of childbearing potential unwilling to use effective contraception. 17. History of severe allergic reactions to foods/supplements similar to the study product (e.g., deer/velvet, citrus components). 18. Participation in another clinical trial or use of an investigational product within the past 3 months. 19. Any medication affecting exercise capacity or heart rate (e.g., beta-blockers, stimulants) that cannot be stopped per protocol. 20. Any condition that, in the investigator’s judgment, makes the subject unsuitable for the study or unable to comply with procedures (e.g., poor adherence risk).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VO2max from baseline to Week 12, estimated by the Ekblom–Bak submaximal cycle-ergometer protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: incidence of AEs/SAEs, vital signs, and routine hematology/chemistry/urinalysis (change from baseline) | — |
Countries
Korea, Republic of
Contacts
Public ContactJong-Hee Kim
Hanyang University
Outcome results
None listed