- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04040010
The Effects of Bovine Colostrum in Bone Metabolism in Humans
Osteoporosis constitutes a major public health concern. For instance, in European Union 1 in 3 women and at least 1 in 6 men will suffer an osteoporotic fracture during their lifespan. The burden of osteoporosis is estimated to raise 25% by 2025. Worldwide, by 2050, the incidence of osteoporotic fractures is expected to increase 240% in women and 310% in men compared to 1990. The aforementioned estimates might indicate the existence of some gaps related to current products on the market for prevention and treatment of osteoporosis. Actually, the use of the approved pharmacological agents for osteoporosis have been decreasing in European Union and worldwide. Patients are becoming increasingly reluctant to take medicines; even those with severe osteoporosis are refusing treatment. Recent published reports on the matter revealed that patients fear the side effects of current pharmacological agents. Actually, therapy with bisphosphonates, the most prescribed medication for the treatment of postmenopausal, glucocorticoid-induced and male osteoporosis has been associated with severe side effects as osteonecrosis of the jaw and atypical femoral fractures.
Colostrum, a milky substance produced by mammals, known to be responsible for the development of the immune and skeleton systems of the offspring, has on its constituent's lactoferrin (LF). This multi-functional protein has been shown to affect both bone resorbing and bone formation pathways. The safety and tolerance on the use of bovine colostrum in humans (children and adults) have been well documented; it has a 'Generally Recognized As Safe' status from the United States Food and Drug Administration. Allergies and lactose intolerance, which are main shortcomings of milk consumption, have not been reported in relation to colostrum. Actually, human colostrum and bovine colostrum share the same bioactive components, but bovine sources are more potent than that of human. In accordance, bovine colostrum supplementation has been used in several therapeutic applications as gastrointestinal disorders, allergies and autoimmune diseases, viral and bacterial illnesses, and HIV-associated immunomodulation HIV. However, the effectiveness of bovine colostrum (as a whole and not only LF) to reduce bone losses has not been considered yet. Therefore, this study aims at analyzing the effects of bovine colostrum in diminishing bone mass losses in humans.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Thessaly
-
Tríkala, Thessaly, Greece, 42100
- FAME Lab, Department of Exercise Science, University of Thessaly
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Postmenopausal women (no menses for the last year at least);
- Osteoporosis patients (female): T-score<-2.5 at the femoral neck (or other anatomical site);
- Osteoporosis patients (male): T-score<-2.5 at the femoral neck (or other anatomical site)
- Osteopenia patients (female): T-score<-1.0 at the femoral neck (or other anatomical site);
- Osteopenia patients (male): T-score<-1.0 at the femoral neck (or other anatomical site)
- Patients taking drugs/ supplements for osteoporosis will be accepted in the study after going through a wash-up period
Exclusion Criteria:
- Women with irregular menses (i.e. with no established menopause)
- Patients taking medications for other diseases known to interfere with bone metabolism
- Patients with other chronic diseases (e.g. diabetes)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Postmenopausal women colostrum supplement
|
Participants in the interventions groups (i.e.
colostrum supplementation) will take a colostrum mixture for 5 months (5 times per week; a total of 250ml per day in liquid form).
Participants in the placebo groups (i.e.
controls) will be taking a placebo mixture (a total of 250ml per day in liquid form per dose) for the same period of time.
|
Experimental: Osteoporosis patients colostrum supplement
|
Participants in the interventions groups (i.e.
colostrum supplementation) will take a colostrum mixture for 5 months (5 times per week; a total of 250ml per day in liquid form).
Participants in the placebo groups (i.e.
controls) will be taking a placebo mixture (a total of 250ml per day in liquid form per dose) for the same period of time.
|
Experimental: Osteopenia patients colostrum supplement
|
Participants in the interventions groups (i.e.
colostrum supplementation) will take a colostrum mixture for 5 months (5 times per week; a total of 250ml per day in liquid form).
Participants in the placebo groups (i.e.
controls) will be taking a placebo mixture (a total of 250ml per day in liquid form per dose) for the same period of time.
|
Placebo Comparator: Postmenopausal women placebo
|
Participants in the interventions groups (i.e.
colostrum supplementation) will take a colostrum mixture for 5 months (5 times per week; a total of 250ml per day in liquid form).
Participants in the placebo groups (i.e.
controls) will be taking a placebo mixture (a total of 250ml per day in liquid form per dose) for the same period of time.
|
Placebo Comparator: Osteoporosis patients placebo
|
Participants in the interventions groups (i.e.
colostrum supplementation) will take a colostrum mixture for 5 months (5 times per week; a total of 250ml per day in liquid form).
Participants in the placebo groups (i.e.
controls) will be taking a placebo mixture (a total of 250ml per day in liquid form per dose) for the same period of time.
|
Placebo Comparator: Osteopenia patients placebo
|
Participants in the interventions groups (i.e.
colostrum supplementation) will take a colostrum mixture for 5 months (5 times per week; a total of 250ml per day in liquid form).
Participants in the placebo groups (i.e.
controls) will be taking a placebo mixture (a total of 250ml per day in liquid form per dose) for the same period of time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of alkaline phosphatase (μg/L)
Time Frame: Change from baseline of alkaline phosphatase at five months
|
The alkaline phosphatase (μg/L) will be analyzed via human serum samples using an appropriate ELISA kit
|
Change from baseline of alkaline phosphatase at five months
|
Change of osteocalcin (μg/L)
Time Frame: Change from baseline of osteocalcin at five months
|
The osteocalcin (μg/L) will be analyzed via human serum samples using an appropriate ELISA kit
|
Change from baseline of osteocalcin at five months
|
Change of deoxypyridinoline (mmol/L)
Time Frame: Change from baseline of deoxypyridinoline at five months
|
The deoxypyridinoline (mmol/L) will be analyzed via human serum samples using an appropriate ELISA kit
|
Change from baseline of deoxypyridinoline at five months
|
Change of C-terminal telopeptide (CTX) (pg/mL)
Time Frame: Change from baseline of C-terminal telopeptide at five months
|
The C-terminal telopeptide (CTX) (pg/mL) will be analyzed via human serum samples using an appropriate ELISA kit
|
Change from baseline of C-terminal telopeptide at five months
|
Change of bone mineral density (g/cm2)
Time Frame: Change from baseline of bone mineral density at five months
|
The bone mineral density (g/cm2) will be analyzed via Dual-energy X-ray absorptiometry scan
|
Change from baseline of bone mineral density at five months
|
Change of bone mineral content (gr)
Time Frame: Change from baseline of bone mineral content at five months
|
The bone mineral content (gr) will be analyzed via Dual-energy X-ray absorptiometry scan
|
Change from baseline of bone mineral content at five months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3. Colostrum & bone
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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