None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 60 generally healthy post-menopausal women aged 50 to 80 years will be randomly assigned to receive a phyto-blend comprising Cuscuta chinensis and Cnidium monnieri (Osteosine), or a placebo for 180 days (6 months). Changes in blood markers of bone turnover comprising Procollagen type 1 N-terminal Propeptide (PINP) and ß-isomerized C-terminal telopeptide (ß-CTX) will be measured at the beginning and end of supplementation to examine the effects of supplementation on bone turnover. A self-report questionnaire will also be regularly administered to examine changes in quality of life.
Interventions
Cuscuta chinensis and Cnidium monnieri extract (Osteosine) (1 capsule taken orally, once daily, after dinner with or without food, delivering 100mg a day for 180 days). Adherence to capsule intake will be measured by a count of capsules returned on day 180
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women aged between 50 and 80 years 2. Postmenopausal women (no menses for at least 12 months) 3. Non-smoker 4. BMI between 18 and 35 kg/m2 5. No plan to commence new treatments over the study period. 6. Understand, willing and able to comply with all study procedures. 7. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Exclusion criteria
1. Diagnosis of osteoporosis 2. Diagnosed with a disease-causing secondary osteoporosis within the last year, such as primary hyperparathyroidism, chronic obstructive pulmonary disease, chronic kidney disease, inflammatory bowel disease, celiac disease, or diabetes. 3. Use of pharmaceutical medications including but not limited to corticosteroids, antiepileptic drugs and antiresorptive therapy, including systemic hormone replacement therapy, bisphosphonates, and strontium ranelate. 4. Commencement of, or change in medication, herbal or vitamin supplements within 4 weeks before starting the study 5. The intake of any supplements known to affect bone metabolism, including vitamin D and mineral supplements. 6. A recent history of fragility fractures, especially those requiring surgical intervention. 7. Planned major lifestyle change in the next 6 months. 8. Alcohol intake greater than 14 standard drinks per week 9. Current or 12-month history of illicit drug use 10. Any significant surgeries over the last year 11. Participation in any other clinical trial in the last month
Outcome results
None listed