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

Sponsor

National and Kapodistrian University of Athens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05421819

Collaborator

National Hellenic Research Foundation (Other)

150

Enrollment

Location

Arms

17.5

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteopenia Postmenopausal Osteopenia	Dietary Supplement: Calcium and vitamin D supplement Dietary Supplement: Calcium, vitamin D and prebiotic supplement Dietary Supplement: Calcium, vitamin D and flavonoid supplement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Calcium and vitamin D supplement In this arm, 50 women will receive calcium and vitamin D supplement once per day.	Dietary Supplement: Calcium and vitamin D supplement 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.
Active Comparator: Calcium, vitamin D and prebiotic supplement In this arm, 50 women will receive calcium, vitamin D and prebiotic supplement once per day.	Dietary Supplement: Calcium, vitamin D and prebiotic supplement 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.
Active Comparator: Calcium, vitamin D, prebiotic and flavonoid supplement In this arm, 50 women will receive calcium, vitamin D, prebiotic and flavonoid supplement once per day.	Dietary Supplement: Calcium, vitamin D and flavonoid supplement 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.

Arm

Intervention/Treatment

Active Comparator: Calcium and vitamin D supplement

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

Dietary Supplement: Calcium and vitamin D supplement

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.

Active Comparator: Calcium, vitamin D and prebiotic supplement

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

Dietary Supplement: Calcium, vitamin D and prebiotic supplement

Active Comparator: Calcium, vitamin D, prebiotic and flavonoid supplement

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

Dietary Supplement: Calcium, vitamin D and flavonoid supplement

Outcome Measures

Primary Outcome Measures

Bone geometry [0 to 12 months]
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 [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 [3, 6 and 12 months]
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 [3, 6 and 12 months]
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 [3, 6 and 12 months]
Secondary endpoint is the within- and between-group comparison change of miRNAs after 3, 6 and 12 months of supplementation.
Change of gut microbiota [12 months]
Secondary endpoint is the within- and between-group comparison change of gut microbiota after 12 months of supplementation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratory for Research of the Musculoskeletal System	Kifissia	Athens	Greece	14561

Sponsors and Collaborators

National and Kapodistrian University of Athens
National Hellenic Research Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

EFSTATHIOS CHRONOPOULOS, Associate Professor in Orthopaedics at National and Kapodistrian University of Athens, Laboratory for Research of the Musculoskeletal System Director, National and Kapodistrian University of Athens

ClinicalTrials.gov Identifier:

NCT05421819

Other Study ID Numbers:

3847/22.03.2022

First Posted:

Jun 16, 2022

Last Update Posted:

Aug 1, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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.:

Keywords provided by EFSTATHIOS CHRONOPOULOS, Associate Professor in Orthopaedics at National and Kapodistrian University of Athens, Laboratory for Research of the Musculoskeletal System Director, National and Kapodistrian University of Athens

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

Additional relevant MeSH terms:

Osteoporosis