None listed
Conditions
Brief summary
This is a clinical trial investigating the effects of synbiotics (prebiotic + probiotic) supplement and/or weight-bearing exercise (10,000 steps per day) on the gut, inflammation status and bone health in postmenopausal women. There have been documented studies that have investigated the benefits of prebiotics, probiotics and exercise on bone health. This formed the basis for this intervention study.
Interventions
Arm 1 will receive pre- and pro-biotic supplements + low impact weight-bearing exercise
Arm 2 will be the control (maltodextrin placebo) + low impact weight-bearing exercise
Prebiotic supplement
10g of prebiotic fiber once daily for 12 weeks by oral capsule
Probiotic supplement
10 billion colony forming units (CFU) of probiotics such as Lactobacillus caseii once daily for 12 weeks by oral tablet
Adherence will be monitored by supplement tablet return
Low impact weight-bearing exercise (10,000 s
Arm 1 will receive pre- and pro-biotic supplements + low impact weight-bearing exercise Arm 2 will be the control (maltodextrin placebo) + low impact weight-bearing exercise Prebiotic supplement 10g of prebiotic fiber once daily for 12 weeks by oral capsule Probiotic supplement 10 billion colony forming units (CFU) of probiotics such as Lactobacillus caseii once daily for 12 weeks by oral tablet Adherence will be monitored by supplement tablet return Low impact weight-bearing exercise (10,000 steps per day) The exercise adherence will be monitored by a clip-on wearable fitness tracker by fitbit given to the recruited participants by the lead investigator and returned for analysis. The women will be required to wear the fitness tracker daily and complete the exercise at home for 12 weeks. The Borg Rating of Perceived Exertion (RPE) will be used to calculate intensity.
Sponsors
Massey University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Healthy volunteers
No
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.
Outcome results
None listed