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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CL22205
Dietary supplement200 mg, Route : Oral, One capsule a day after breakfast for 360 days
Placebo
Other interventionRoute : Oral, One capsule a day after breakfast for 360 days
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: CL22205Experimental treatment 1 intervention
Group B: PlaceboOther 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline to the end of the study period in : Bone Mineral density (BMD) (g/cm2) of Lumbar spine (L1-L4)
A low-dose X-ray is used to assess the bone mineral content (density) in specific areas, such as the lumbar spine at L1-L4 region. The results are typically expressed in terms of the T-score. If T scores ≥-1 signifies healthy bone, a range from -1 to -2.5 indicates osteopenia and a score of ≤-2.5 indicates osteoporosis.
Time frame
Screening/Baseline, Days 180 & 360Secondary outcomes
1
Change from baseline to the end of the study period in : Lean body mass through DEXA
Dual-energy X-ray absorptiometry (DEXA) uses two X-ray beams with different energies to measure lean body mass in Kilograms. Higher ranges reflect a greater proportion of lean tissue.
Time frame
Screening/Baseline, Days 180 & 3602
Change from baseline to the end of the study period in : Scores of modified Kupperman index (mKI)
The modified Kupperman Index (mKI) is a tool used to assess the severity of menopausal symptoms. The total score ranges from 0 to 63, calculated as the sum of all items by the weighting factor. Scores ranging from 0-6, 7-15, 16-30, and \>30 were used to rate the degree of severity as none, mild, moderate, and severe, respectively.
Time frame
Screening, Baseline/Day 1, Days 90,180 & 3603
Change from baseline to the end of the study period in: Hand grip-strength
Grip strength was a measure of muscular strength (in kgs) or the maximum force/tension generated by one's forearm muscles. The Hand grip strength was measured using digital hand dynamometer.
Time frame
Baseline/Day 1, Days 90,180 & 3604
Change from baseline to the end of the study period in: Chalder Fatigue Scale (CFS)
The Fatigue Scale, sometimes referred to as the Chalder Fatigue Scale, is a self-administered questionnaire for measuring the extent and severity of fatigue within both clinical and non-clinical, epidemiological populations. Items are rated on a 4-point Likert scale (0, 1, 2, 3), with higher scores indicating greater fatigue. The respondent's global score can range from 0 to 33.
Time frame
Baseline/Day 1, Days 90,180 & 360Other outcomes
1
Telephonic evaluation: Modified Kupperman index (mKI)
The modified Kupperman Index is a tool used to assess the severity of menopausal symptoms. The total score ranges from 0 to 63, with scores of 0-6, 7-15, 16-30, and over 30 used to classify the severity as none, mild, moderate, and severe, respectively.
Time frame
Monthly (Every month between evaluation days)2
Telephonic evaluation: Chalder Fatigue Scale (CFS)
Chalder Fatigue Scale is used to measuring the extent and severity of fatigue. Items are rated on a 4-point Likert scale (0, 1, 2, 3), with higher scores indicating greater fatigue. The respondent's global score can range from 0 to 33.
Time frame
Monthly (Every month between evaluation days)3
Telephonic evaluation: Female Sexual Function Index (FSFI)
The Female Sexual Function Index was developed for assessing key dimensions or domains of sexual function and quality of life in women. The total FSFI score ranges from 2 to 36. Greater Scores indicates better sexual function.
Time frame
Monthly (Every month between evaluation days)4
Telephonic evaluation: Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval. Global PSQI score range of 0-21, with higher scores indicating more acute sleep disturbances.
Time frame
Monthly (Every month between evaluation days)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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