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

Not Applicable

Completed

• Conditions: Osteopenia; Postmenopausal Osteopenia
• Interventions: Dietary Supplement: Calcium and vitamin D supplement; Dietary Supplement: Calcium, vitamin D and flavonoid supplement; Dietary Supplement: Calcium, vitamin D and prebiotic supplement

• Registration Number: NCT05421819
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-06-14
• Study Start: 2022-06-15
• Study First Posted: 2022-06-16
• Primary Completion: 2023-12-15
• Study Completion: 2024-01-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 117

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Laboratory for Research of the Musculoskeletal System; 🇬🇷 Kifissia, Athens, Greece