Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms: Efficacy and Tolerability Assessment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Bone geometry
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Calcium and vitamin D supplement
In this arm, 50 women will receive calcium and vitamin D supplement once per day.
Intervention: Calcium and vitamin D supplement (Dietary Supplement)
Calcium, vitamin D and prebiotic supplement
In this arm, 50 women will receive calcium, vitamin D and prebiotic supplement once per day.
Intervention: Calcium, vitamin D and prebiotic supplement (Dietary Supplement)
Calcium, vitamin D, prebiotic and flavonoid supplement
In this arm, 50 women will receive calcium, vitamin D, prebiotic and flavonoid supplement once per day.
Intervention: Calcium, vitamin D and flavonoid supplement (Dietary Supplement)
Outcomes
Primary Outcomes
Bone geometry
Time Frame: 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 Outcomes
- 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)
Investigators
EFSTATHIOS CHRONOPOULOS
Associate Professor in Orthopaedics at National and Kapodistrian University of Athens, Laboratory for Research of the Musculoskeletal System Director
National and Kapodistrian University of Athens