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

National and Kapodistrian University of Athens

Status: Completed

Conditions: Osteopenia; Postmenopausal Osteopenia

Treatments: Dietary Supplement: Calcium, vitamin D and flavonoid supplement; Dietary Supplement: Calcium, vitamin D and prebiotic supplement; Dietary Supplement: Calcium and vitamin D supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05421819

3847/22.03.2022

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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117 participants in 3 patient groups

Calcium and vitamin D supplement

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Calcium and vitamin D supplement

Calcium, vitamin D and prebiotic supplement

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Calcium, vitamin D and prebiotic supplement

Calcium, vitamin D, prebiotic and flavonoid supplement

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Calcium, vitamin D and flavonoid supplement