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Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms (OSTEOME)

Primary Purpose

Osteopenia, Postmenopausal Osteopenia

Status

Recruiting

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Calcium and vitamin D supplement

Calcium, vitamin D and prebiotic supplement

Calcium, vitamin D and flavonoid supplement

About this trial

This is an interventional prevention trial for Osteopenia focused on measuring Dietary supplement for osteopenia, Calcium and vitamin D supplement, Calcium, vitamin D and prebiotics supplement, Calcium, vitamin D, prebiotics and flavonoids supplement, Bone turnover markers, Bone mineral density, Volumetric bone mineral density, Bone geometry, Postmenopausal osteopenia, Gut microbiota analysis

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Postmenopausal women
T-score in the osteopenic range (-1.0 > T-score > -2.5) at either the lumbar spine (LS) or femur as measured by dual energy X-ray absorptiometry (DXA)

Exclusion Criteria:

T-score in the osteoporotic range (T-score < -2.5) at any site
Patients receiving supplements of calcium and/or vitamin D at that time or during the last 6 months
Patients receiving medications known to positively or negatively affect bone turnover or BMD at that time or during the last 3 years (e.g. antiresorptive agents, oestrogens, systemic corticosteroids), or
Secondary cause of osteoporosis (e.g. alcohol abuse, thyrotoxicosis etc)
Patients who did not attend to their follow-up appointment and consequently had only the baseline measurements

Sites / Locations

Laboratory for Research of the Musculoskeletal SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Calcium and vitamin D supplement

Calcium, vitamin D and prebiotic supplement

Calcium, vitamin D, prebiotic and flavonoid supplement

Arm Description

In this arm, 50 women will receive calcium and vitamin D supplement once per day.

In this arm, 50 women will receive calcium, vitamin D and prebiotic supplement once per day.

In this arm, 50 women will receive calcium, vitamin D, prebiotic and flavonoid supplement once per day.

Outcomes

Primary Outcome Measures

Bone geometry

The primary endpoint is the within and between group change of bone geometry after 12 months of supplementation assessed by peripheral quantitative computed tomography (pQCT) of the tibia

Secondary Outcome Measures

Areal bone mineral density (aBMD), trabecular bone score (TBS), adverse effects (tolerability) and adherence to dietary supplement after 12 months

The secondary endpoints is the within- and between-groups differences of the areal BMD (aBMD) at the lumbar spine (LS) and the total hip (TH) using dual-energy X-ray absorptiometry (DXA) and trabecular bone score (TBS) at LS, and the between-group comparison of the adverse effects (tolerability) and adherence to dietary supplement after 12 months.

Bone turnover markers, PINP and CTX

Secondary endpoint is the within- and between-group comparison change of bone turnover markers after 3, 6 and 12 months of supplementation.

Change of serum TNF-α, IL-1, OPG, RANKL and IGF-1

Secondary endpoint is the within- and between-group comparison change of TNF-α, IL-1, OPG, RANKL and IGF-1 after 3, 6 and 12 months of supplementation.

Change of microMR1 Change of serum miRNAs

Secondary endpoint is the within- and between-group comparison change of miRNAs after 3, 6 and 12 months of supplementation.

Change of gut microbiota

Secondary endpoint is the within- and between-group comparison change of gut microbiota after 12 months of supplementation.

Full Information

NCT ID

NCT05421819

First Posted

May 26, 2022

Last Updated

July 27, 2022

Sponsor

National and Kapodistrian University of Athens

Collaborators

National Hellenic Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05421819

Brief Title

Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms

Acronym

OSTEOME

Official Title

Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms: Efficacy and Tolerability Assessment

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 15, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National and Kapodistrian University of Athens

Collaborators

National Hellenic Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

It is well proven that the intestinal microbe regulates bone metabolism by the absorption of calcium and other metallic trace elements. Studies also show that regulation of the intestine and its microbe can affect bone density and resistance to a variety of animal models and humans. At the same time, interest in polyphenol-intestinal microbial interactions and in particular flavonoids and catechins has increased. Indeed, it has been observed that they are transformed via the microbe into bioactive compounds, and polyphenols themselves can modify the synthesis of the intestinal microbe. OSTEOME aspires to design and develop a novel dietary supplement for osteoporosis, activating the intestinal microbiome. At the same time companion biomarkers will be studied related to the efficacy and tolerability of the new supplement. The selection of flavonoids will take place through in vitro and in silico studies focusing on their interaction with pathways that regulate the activity of osteoclasts and osteoblasts. The efficacy and tolerability of the dietary supplement will be evaluated through a randomized clinical intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteopenia, Postmenopausal Osteopenia

Keywords

Dietary supplement for osteopenia, Calcium and vitamin D supplement, Calcium, vitamin D and prebiotics supplement, Calcium, vitamin D, prebiotics and flavonoids supplement, Bone turnover markers, Bone mineral density, Volumetric bone mineral density, Bone geometry, Postmenopausal osteopenia, Gut microbiota analysis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Calcium and vitamin D supplement

Arm Type

Active Comparator

Arm Description

In this arm, 50 women will receive calcium and vitamin D supplement once per day.

Arm Title

Calcium, vitamin D and prebiotic supplement

Arm Type

Active Comparator

Arm Description

In this arm, 50 women will receive calcium, vitamin D and prebiotic supplement once per day.

Arm Title

Calcium, vitamin D, prebiotic and flavonoid supplement

Arm Type

Active Comparator

Arm Description

In this arm, 50 women will receive calcium, vitamin D, prebiotic and flavonoid supplement once per day.

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium and vitamin D supplement

Intervention Description

One hundred fifty postmenopausal women with osteopenia will be randomly and blindly allocated to receive in of the 3 different dietary supplements once per day. Patients of group A will receive orally 600 mg calcium and 2400 IU vitamin D3, group B will receive the same dose of calcium and vitamin D3 plus prebiotics once per day and group C will receive the same dose of calcium, vitamin D3 plus flavonoids once per day.

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium, vitamin D and prebiotic supplement

Intervention Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium, vitamin D and flavonoid supplement

Intervention Description

Primary Outcome Measure Information:

Title

Bone geometry

Description

The primary endpoint is the within and between group change of bone geometry after 12 months of supplementation assessed by peripheral quantitative computed tomography (pQCT) of the tibia

Time Frame

0 to 12 months

Secondary Outcome Measure Information:

Title

Areal bone mineral density (aBMD), trabecular bone score (TBS), adverse effects (tolerability) and adherence to dietary supplement after 12 months

Description

Time Frame

12 months

Title

Bone turnover markers, PINP and CTX

Description

Secondary endpoint is the within- and between-group comparison change of bone turnover markers after 3, 6 and 12 months of supplementation.

Time Frame

3, 6 and 12 months

Title

Change of serum TNF-α, IL-1, OPG, RANKL and IGF-1

Description

Secondary endpoint is the within- and between-group comparison change of TNF-α, IL-1, OPG, RANKL and IGF-1 after 3, 6 and 12 months of supplementation.

Time Frame

3, 6 and 12 months

Title

Change of microMR1 Change of serum miRNAs

Description

Secondary endpoint is the within- and between-group comparison change of miRNAs after 3, 6 and 12 months of supplementation.

Time Frame

3, 6 and 12 months

Title

Change of gut microbiota

Description

Secondary endpoint is the within- and between-group comparison change of gut microbiota after 12 months of supplementation.

Time Frame

12 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Postmenopausal women with osteopenia

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Postmenopausal women T-score in the osteopenic range (-1.0 > T-score > -2.5) at either the lumbar spine (LS) or femur as measured by dual energy X-ray absorptiometry (DXA) Exclusion Criteria: T-score in the osteoporotic range (T-score < -2.5) at any site Patients receiving supplements of calcium and/or vitamin D at that time or during the last 6 months Patients receiving medications known to positively or negatively affect bone turnover or BMD at that time or during the last 3 years (e.g. antiresorptive agents, oestrogens, systemic corticosteroids), or Secondary cause of osteoporosis (e.g. alcohol abuse, thyrotoxicosis etc) Patients who did not attend to their follow-up appointment and consequently had only the baseline measurements

Facility Information:

Facility Name

Laboratory for Research of the Musculoskeletal System

City

Kifissia

State/Province

Athens

ZIP/Postal Code

14561

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Efstathios Chronopoulos, Ass. Prof.

Phone

00306944837793

stathi24@yahoo.gr

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms

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