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

NACompletedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

June 15, 2022

Primary Completion Date

December 15, 2023

Study Completion Date

January 24, 2024

Conditions
OsteopeniaPostmenopausal Osteopenia
Interventions
DIETARY_SUPPLEMENT

Calcium and vitamin D 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.

DIETARY_SUPPLEMENT

Calcium, vitamin D and prebiotic 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.

DIETARY_SUPPLEMENT

Calcium, vitamin D and flavonoid 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.

Trial Locations (1)

14561

Laboratory for Research of the Musculoskeletal System, Kifissia

All Listed Sponsors
collaborator

National Hellenic Research Foundation

OTHER

lead

National and Kapodistrian University of Athens

OTHER