NCT05421819Completed
Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms
Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms: Efficacy and Tolerability Assessment
Source: ClinicalTrials.gov · Last updated 7 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 117 (actual)
- First submitted
- 26 May 2022
- Start date
- 15 Jun 2022
- Primary completion date
- 15 Dec 2023
- Lead sponsor
- National and Kapodistrian University of Athens
- Diseases
- Osteoporosis
- NCT number
- NCT05421819
What you commit to
- Study type: Interventional
- Participants enrolled: 117
- From 15 Jun 2022 to the primary completion date, 15 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Lab values
- Patients receiving supplements of calcium and/or vitamin D at that time or during the last 6 months
Other
- T-score in the osteoporotic range (T-score \< -2.5) at any site
- 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
Who the study is looking for
- 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)
Age in the registry: 50 years to 70 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Laboratory for Research of the Musculoskeletal System Coordinator of this site? Confirm its status | Kifissia | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.