The Effects of Bovine Colostrum in Bone Metabolism in Humans

Osteoporosis Clinical Trial

Official title:

The Effects of Bovine Colostrum in Bone Metabolism in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04040010
• Other study ID #: 3. Colostrum & bone
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: November 2020
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Postmenopausal women (without any bone condition), osteopenia and osteoporosis patients (female and male) will be invited to join the study. Participants enrolling the project will be first measured on the following parameters: 1) general characteristics (age, sex, medical history); 2) bone mass parameters through Dual-energy X-ray absorptiometry (DXA); 3) bone formation and resorption markers (alkaline phosphatase, osteocalcin, N-telopeptides and urine deoxypyridinoline). After measuring the aforementioned parameters, consenting participants will be randomized into the following groups: Group 1: postmenopausal women taking colostrum supplementation; Group 2: postmenopausal women taking placebo; Group 3: osteopenia patients taking colostrum supplementation; Group 4: osteopenia patients taking placebo; Group 5: osteoporosis patients taking colostrum supplementation; Group 6: osteoporosis patients taking placebo. Power calculations (90% power, 0.05%) were performed in order to calculate the sample size needed in each group (considering stratification according to group, a minimum of 7 participants in each group are needed). Following 5 months intervention, participants will be re-assessed on the following parameters: 1) general characteristics (age, sex, medical history); 2) bone mass parameters through Dual-energy X-ray absorptiometry (DXA); 3) bone formation and resorption markers (alkaline phosphatase, osteocalcin, N-telopeptides and urine deoxypyridinoline).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia
• Osteoporosis

Intervention

Dietary Supplement:
• Colostrum supplementation for bone loss
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.

Locations

Country	Name	City	State
Greece	FAME Lab, Department of Exercise Science, University of Thessaly	Tríkala	Thessaly

Sponsors (2)

Lead Sponsor	Collaborator
Petros Dinas	European Commission

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of alkaline phosphatase (µg/L)	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
Primary	Change of osteocalcin (µg/L)	The osteocalcin (µg/L) will be analyzed via human serum samples using an appropriate ELISA kit	Change from baseline of osteocalcin at five months
Primary	Change of deoxypyridinoline (mmol/L)	The deoxypyridinoline (mmol/L) will be analyzed via human serum samples using an appropriate ELISA kit	Change from baseline of deoxypyridinoline at five months
Primary	Change of C-terminal telopeptide (CTX) (pg/mL)	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
Primary	Change of bone mineral density (g/cm2)	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
Primary	Change of bone mineral content (gr)	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