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The Effects of Bovine Colostrum in Bone Metabolism in Humans

NCT ID: NCT04040010

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-02-29

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Osteopenia Osteoporosis

Keywords

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bone metabolism Postmenopausal women bone markers bovine colostrum DXA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Postmenopausal women colostrum supplement

Group Type EXPERIMENTAL

Colostrum supplementation for bone loss

Intervention Type 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.

Osteoporosis patients colostrum supplement

Group Type EXPERIMENTAL

Colostrum supplementation for bone loss

Intervention Type 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

Group Type EXPERIMENTAL

Colostrum supplementation for bone loss

Intervention Type 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.

Postmenopausal women placebo

Group Type PLACEBO_COMPARATOR

Colostrum supplementation for bone loss

Intervention Type 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.

Osteoporosis patients placebo

Group Type PLACEBO_COMPARATOR

Colostrum supplementation for bone loss

Intervention Type 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 placebo

Group Type PLACEBO_COMPARATOR

Colostrum supplementation for bone loss

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Commission

OTHER

Sponsor Role collaborator

Petros Dinas

OTHER

Sponsor Role lead

Responsible Party

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Petros Dinas

Senior Researcher in human physiology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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FAME Lab, Department of Exercise Science, University of Thessaly

Trikala, Thessaly, Greece

Site Status

Countries

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Greece

Other Identifiers

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3. Colostrum & bone

Identifier Type: -

Identifier Source: org_study_id