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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
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Active Comparator

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

First Posted
May 26, 2022
Last Updated
July 27, 2022
Sponsor
National and Kapodistrian University of Athens
Collaborators
National Hellenic Research Foundation
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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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

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
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 and flavonoids once per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium, vitamin D and flavonoid 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 and flavonoids once per day.
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
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.
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
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
Email
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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