Osteoporosis, Postmenopausal
Conditions
Brief summary
The primary objective of this study is to investigate the effects of 12-months supplementation with calcium-enriched permeate, taken alone or in conjunction with inulin, on changes in markers of bone formation and resorption and in bone mass density (BMD) in apparently healthy postmenopausal women compared with calcium-carbonate or maltodextrin supplementation.
Detailed description
The study will include an information visit, a randomization visit, a month 3 visit and a final visit at month 12. Besides, two visits at month 6 and 9 for dispensing of trial products. Outcome parameters will be measured using blood samples obtained at the randomization visit, the month 3 visit and at the final visit at month 12. Outcome parameters will moreover be analyzed based on DXA scan obtained at the randomization visit and at the final visit at 12 months.
Interventions
DIETARY_SUPPLEMENTMaltodextrin
Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
DIETARY_SUPPLEMENTCalcium-carbonate
Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
DIETARY_SUPPLEMENTCalcium-enriched permeate
Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
DIETARY_SUPPLEMENTCalcium-enriched permeate with Inulin
Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
Sponsors
Zealand University Hospital
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is between 45 years and 65 years of age by the time of inclusion. * Subject has been menopausal for at least 1 year, defined as 12 months after last bleeding and up to 10 years. * Subject is Caucasian. * Has a BMI below 35.0. * Holder of a computer. * Has a sufficient vitamin D status (plasma 25OHD concentration \> 50 nmol/L). * Subject is willing and able to provide written informed consent prior to participation.
Exclusion criteria
* Subject taking supplements or medicine that affects calcium and bone metabolism e.g. diuretics or hormone replacement therapy evaluated by the investigator. * Intake of antibiotics in the last 3 months before enrollment. * Subject with an osteoporosis diagnosis or history of osteoporotic fractures. * Presence of renal, gastrointestinal, hepatic or endocrinological diseases. * Subject with any serious illness or history of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer). * Known or suspected abuse of alcohol or recreational drugs. * Known milk allergy. * Known or suspected hypersensitivity to trial products or related products. * Blood donation except from the donation in this study. * Subject where it is not possible to obtain sufficient data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in bone turnover marker CTX. | 1 year | Changes in fasting blood samples of bone turnover marker CTX attained at randomization, 3 months visit and 12 months visit (final visit) |
| The change in loss of bone mineral density. | 1 year | Changes in DXA scan results of BMD (femur) and BMD (lumbar spine) attained at randomization and 12 months visit (final visit) |
| The change in bone turnover marker P1NP. | 1 year | Changes in fasting blood samples of bone turnover marker (P1NP) attained at randomization, 3 months visit and 12 months visit (final visit) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood parameters of iPTH | 1 year | Changes in fasting blood samples of iPTH attained at randomization and 12 months visit (final visit) |
| Changes in blood parameters of Vitamin D | 1 year | Changes in fasting blood samples of vitamin D attained at randomization and 12 months visit (final visit) |
| Changes in blood parameters of total calcium | 1 year | Changes in fasting blood samples of total calcium attained at randomization and 12 months visit (final visit) |
| Changes in blood parameters of phosphate | 1 year | Changes in fasting blood samples of phosphate attained at randomization and 12 months visit (final visit) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in BMI | 1 year | Changes in BMI from randomization to 12 months visit (final visit) |
| Changes in fecal pH | 1 year | Changes in fecal pH from randomization to 12 months visit (final visit) |
| Changes in habitual dietary intake | 1 year | Changes in habitual dietary intake attained by Myfood24 7-day recording from randomization to 12 months visit (final visit) |
| Changes in physical activity | 1 year | Changes in physical activity level attained by IPAQ from randomization to 12 months visit (final visit) |
| Changes in gut microbiome | 1 year | Changes in microbial taxonomy and microbial gene content measured via sequencing of DNA extracted from fecal samples from randomization to 12 months visit (final visit) |
| Changes in urinary metabolites | 1 year | Changes in urine metabolites from randomization to 12 months visit (final visit) by NMR spectroscopy to detect and quantify about 50 metabolites including creatinine, amines, amino acids, alcohols, carboxylic acids including short-chain fatty acids, keto acids, purine, pyridine and pyrimidine derivatives, sugars and derivatives. |
| Changes in fecal metabolites | 1 year | Changes in fecal metabolites from randomization to 12 months visit (final visit) by NMR spectroscopy to detect and quantify about 50 metabolites including creatine, creatinine, amines, amino acids, carboxylic acids including short-chain fatty acids, keto acids, nucleotides and derivatives. |
Countries
Denmark
Outcome results
None listed