Healthy Aging
Conditions
Brief summary
To evaluate the effect and support the tolerance of orally ingested formulation containing Eurycoma longifolia dietary supplement (Euryco-10) on a cohort of senior men.
Detailed description
This is a single-center, single arm, open label study in senior men. This study will investigate the effect and tolerance of oral ingestion of Euryco-10. Subjects meeting all inclusion and none of the exclusion criteria will be enrolled and provided with study dietary supplement. Subjects will be instructed to take 2 capsules per day for 35 days. Administration and any adverse events will be recorded in the subject diary. At each clinic visit (Day 0, Day 21 and Day 35) the Subject will complete the AMS Questionnaire.
Interventions
None listed
Sponsors
Innovus Pharmaceuticals, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
MALE
Age
55 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Male ≥ 55 years of age
Exclusion criteria
Severe lower urinary tract symptoms. Current use of any herbal and/or nutritional supplements that can interfere with testosterone. A history of cancer except melanoma skin cancer. Currently receiving treatment with cancer chemotherapy or antiandrogens. Chronic use of systemic glucocorticoids (use within \>14 days up to the 3months prior to screening); use of non-testosterone anabolic steroids within12 months prior to screening. History of frequent opioid use \>1 time/week during any week within 30 days prior to screening. Have a history of known angina. Have a history of severe liver disease or clinical evidence of hepatic impairment at screening. Untreated severe obstructive sleep apnea. Allergies to any of the ingredients in Euryco-10® or BioPerine. Any condition which would interfere with the subject's ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum total testosterone concentration compared to baseline | Day 0, Day 21 and Day 35 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Q 9 of the AMS Questionnaire | Day 0, Day 21 and Day 35 |
| Change in Q17 of the AMS Questionnaire | Day 0, Day 21 and Day 35 |
Countries
United States
Outcome results
None listed