Prevention of osteoporotic fractures in postmenopausal women Musculoskeletal Diseases
Conditions
Interventions
Inulin-propionate ester (Intervention): 10 g/day for 8 weeks. Incorporated into habitual diet.
Cellulose (Control): 10 g/day for 8 weeks. Incorporated into habitual diet
Randomisation will be conduc
Sponsors
Imperial College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Post-menopausal females (>5 years post-menopause) 2. Healthy non-obese volunteers (body mass index (BMI) of 20-30 kg/m²) 3. Age between 50-75 years (inclusive) 4. Non-diabetic (HbA1c <48 mmol/mol)
Exclusion criteria
Exclusion criteria: 1. Weight change of = 3kg in the preceding 2 months 2. Current smokers 3. Substance abuse 4. Excess alcohol intake 5. Cardiovascular disease 6. Cancer 7. Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome 8. Kidney disease 9.Pancreatitis 10. Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Carboxy-terminal telopeptide of type I collagen (CTX-I) is measured at baseline, week 2, and week 8 in fasting and postprandial blood samples 2. N-telopeptide of type I collagen (NTX-I) is measured at baseline, week 2, and week 8 in fasting and postprandial blood samples 3. N-terminal propeptide of type I procollagen (PINP) is measured at baseline, week 2, and week 8 in fasting and postprandial blood samples 4. Osteocalcin is measured at baseline, week 2, and week 8 in fasting and postprandial blood samples 5. Bone specific alkaline phosphatase (BAP) is measured at baseline, week 2, and week 8 in fasting and postprandial blood samples 6. N-telopeptide of type I collagen (NTX-I) is measured at baseline, week 2, and week 8 in urine samples | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Short chain fatty acids (SCFA) are measured in blood samples and stool samples at baseline and week 8 2. Glucose homeostasis is measured using blood glucose, insulin, HbA1c, and insulin-like growth factor 1 (IGF-1) at baseline and week 8 3. Immune function is measured using inflammatory cytokines and immune phenotyping of peripheral blood mononuclear cells (PBMCs) at baseline and week 8 4. Gut barrier function is measured using lipopolysaccharide (LPS) in blood samples and calprotectin and zonulin in stool samples at baseline and week 8 5. Calcium and Vitamin D metabolism is measured using parathyroid hormone and Vitamin D 25-hydroxy in blood samples at baseline and week 8 | — |
Countries
England, United Kingdom
Contacts
Public ContactEdward Chambers
Outcome results
None listed