Clinical trial NCT05421819: Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms
Official title: Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms: Efficacy and Tolerability Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: National Hellenic Research Foundation
First posted: 2022-06-16
Enrollment: 117
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bone geometry
timeFrame: 0 to 12 months
Secondary outcomes:
measure: Areal bone mineral density (aBMD), trabecular bone score (TBS), adverse effects (tolerability) and adherence to dietary supplement after 12 months
timeFrame: 12 months
measure: Bone turnover markers, PINP and CTX
timeFrame: 3, 6 and 12 months
measure: Change of serum TNF-α, IL-1, OPG, RANKL and IGF-1
timeFrame: 3, 6 and 12 months
measure: Change of microMR1 Change of serum miRNAs
timeFrame: 3, 6 and 12 months
measure: Change of gut microbiota
timeFrame: 12 months
Other outcomes:
Locations:
city: Kifissia
country: Greece
facility: Laboratory for Research of the Musculoskeletal System
state: Athens
Study officials:
References: