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

NCT05421819 | Completed

• 1 other identifier: 3847/22.03.2022
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  12 months

• Bone turnover markers, PINP and CTX

  3, 6 and 12 months

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

  3, 6 and 12 months

• Change of microMR1 Change of serum miRNAs

  3, 6 and 12 months

• Change of gut microbiota

  12 months

Study Arms (3)

Calcium and vitamin D supplement

ACTIVE COMPARATOR

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

Dietary Supplement: Calcium and vitamin D supplement

Calcium, vitamin D and prebiotic supplement

ACTIVE COMPARATOR

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

Dietary Supplement: Calcium, vitamin D and prebiotic supplement

Calcium, vitamin D, prebiotic and flavonoid supplement

ACTIVE COMPARATOR

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

Interventions

Calcium and vitamin D supplement DIETARY_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 and vitamin D supplement

Calcium, vitamin D and prebiotic supplement DIETARY_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 prebiotic supplement

Calcium, vitamin D and flavonoid supplement DIETARY_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, prebiotic and flavonoid supplement

Eligibility Criteria

• Age: 50 Years - 70 Years
• Gender Eligibility Details: Postmenopausal women with osteopenia
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• National Hellenic Research Foundation: collaborator

Study Sites (1)

Laboratory for Research of the Musculoskeletal System

Kifissia, Athens, 14561, Greece

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Calcium; Vitamin D

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Orthopaedics at National and Kapodistrian University of Athens, Laboratory for Research of the Musculoskeletal System Director

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 16, 2022
• Study Start: June 15, 2022
• Primary Completion: December 15, 2023
• Study Completion: January 24, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

GR (1)