COPES 4 Bones: Combination of Physical Exercise and Synbiotic (pre- and probiotic) supplements for postmenopausal wome

Not Applicable

Completed

• Conditions: bone health; Gut microbiota; inflammation; Menopause; Inflammatory and Immune System - Other inflammatory or immune system disorders; Musculoskeletal - Osteoporosis; Musculoskeletal - Osteoarthritis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12620000998943
• Lead Sponsor: Massey University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-06
• Study Completion: 2022-11-24
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

Confirmed menopause [by an initial blood test (baseline screening) that includes checking of levels of follicle-stimulating hormone (FSH greater than or equal to 30 mIU/mL) and oestrogen] of at least 5 years based on no menstruation. Body Mass Index (BMI) between 17 and 35 kg/m².

Exclusion Criteria

1.Use of hormone replacement therapy (HRT).
2.Biphosphonates in last 6 months.
3.Currently on estrogen, tamoxifen, Aromatase Inhibitors or other antiresorptive or anabolic treatment of osteoporosis
4.Liver function test or creatinine above the normal range, or any other history suggesting liver or kidney disease to be confirmed by the baseline screening.
5.Incidence of diabetes mellitus by using the questionnaire and baseline screening.
6.Subjects with an estimated BMD T-score lower than -2.5 or fragility fracture in the previous 6 months.
7.Antibiotics intake in the previous 6 months
8.Smoking and intake of alcohol > 2 units per day.

Study & Design

• Study Type: Interventional
• Study Design: Not specified