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

Osteopenia Clinical Trial

— OSTEOME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05421819
• Other study ID #: 3847/22.03.2022
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: January 24, 2024

Study information

• Verified date: March 2024
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: January 24, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia
• Osteoporosis
• Postmenopausal Osteopenia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Greece	Laboratory for Research of the Musculoskeletal System	Kifissia	Athens

Sponsors (2)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens	National Hellenic Research Foundation

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0 to 12 months
Secondary	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.	12 months
Secondary	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.	3, 6 and 12 months
Secondary	Change of serum TNF-a, IL-1, OPG, RANKL and IGF-1	Secondary endpoint is the within- and between-group comparison change of TNF-a, IL-1, OPG, RANKL and IGF-1 after 3, 6 and 12 months of supplementation.	3, 6 and 12 months
Secondary	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.	3, 6 and 12 months
Secondary	Change of gut microbiota	Secondary endpoint is the within- and between-group comparison change of gut microbiota after 12 months of supplementation.	12 months