Efficacy of CL22205 on Bone Mineral Density and Menopausal Symptoms
ConditionMenopausal Symptoms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age55-65
SponsorEetho Brands, Inc
About this trial
The purpose of this study is to evaluate the effect of CL22205 on bone mineral density and menopausal symptoms in women.
Eligibility criteria
Qualifiers
Healthy females aged between 55 and 65 years with a Body mass index (BMI) of approximately 24 and 29 kg/m2.
Women with menopausal symptoms (modified Kupperman index scores 15-29), absence of menstrual cycle for past 12-months; follicle-stimulating hormone (FSH) > 30 mIU/mL; estradiol < 30 pg/mL.
Subjects who are under standard supplementation of Vitamin D3 (cholecalciferol) and calcium carbonate.
Subjects with osteopenia (T score of spine between -1 and -2.5 in DEXA).
Disqualifiers
Consumption of functional food or supplement that modifies body composition, during or 6 months prior to the study.
History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years.
Subjects on anti-coagulant or anti-platelet drugs on a daily basis for any conditions.
Presence of chronic diseases that prevent the performance of a physical exercise program (disabling arthropathies, moderate / severe chronic lung disease, arrhythmias, etc.).
Trial design
Treatments tested in this trial
- CL22205
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov