The Effects of Bovine Colostrum in Bone Metabolism in Humans

NCT04040010 | Completed

• 1 other identifier: 3. Colostrum & bone
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteopenia; Osteoporosis

Keywords

bone metabolism; Postmenopausal women; bone markers; bovine colostrum; DXA

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (6)

Postmenopausal women colostrum supplement

EXPERIMENTAL

Dietary Supplement: Colostrum supplementation for bone loss

Osteoporosis patients colostrum supplement

EXPERIMENTAL

Dietary Supplement: Colostrum supplementation for bone loss

Osteopenia patients colostrum supplement

EXPERIMENTAL

Dietary Supplement: Colostrum supplementation for bone loss

Postmenopausal women placebo

PLACEBO COMPARATOR

Dietary Supplement: Colostrum supplementation for bone loss

Osteoporosis patients placebo

PLACEBO COMPARATOR

Dietary Supplement: Colostrum supplementation for bone loss

Osteopenia patients placebo

PLACEBO COMPARATOR

Dietary Supplement: Colostrum supplementation for bone loss

Interventions

Colostrum supplementation for bone loss DIETARY_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.

Osteopenia patients colostrum supplement; Osteopenia patients placebo; Osteoporosis patients colostrum supplement; Osteoporosis patients placebo; Postmenopausal women colostrum supplement; Postmenopausal women placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Petros Dinas: lead
• European Commission: collaborator

Study Sites (1)

FAME Lab, Department of Exercise Science, University of Thessaly

Trikala, Thessaly, 42100, Greece

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher in human physiology

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 31, 2019
• Study Start: September 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

GR (1)