Osteopenia or Osteoporosis
Conditions
Keywords
postmenopausal, osteopenia, osteoporosis, supplements, functional olive paste
Brief summary
It was a prospective randomized controlled trial. A sample of 115 apparently healthy post-menopausal women(45 -75 years of age) randomized into four groups and received supplements of Ca, Vitamin D and Mg with or without enriched olive paste and with or without Vitamin C. Changes in calciregulatory hormone were evaluated at the beginning of the study, at 5 and 12 months . Blood levels of vitamin D, vitamin C, Ca, Mg, the lipid profile, anthropometric indices and bone density were assessed at the beginning and at the end of the study.
Detailed description
: It was a prospective randomized controlled trial. A sample of 115 apparently healthy post-menopausal women(45 -75 years of age) randomized into four groups: (I) nutritional intervention group(n=40) received daily 1000mg vitamin C, 500mg vitamin D3, 500mg calcium(Ca) and 300mg magnesium (Mg); (II) control group(n=42) received daily 500mg vitamin D3, 500mg Ca and 300mg Mg; (III) nutritional intervention group (n=18) received daily 150mg bisphosphonates, 500mg vitamin D3, 500mg Ca and 300mg Mg; and (IV) nutritional intervention group (n=15) received daily about 364 mg polyphenols via an innovative functional food (50g olive paste enriched with mountain tea extract) along with 500mg vitamin D3, 500mg Ca and 300mg Mg. Groups I -III received supplementation for a year whereas group IV for 5 months. Changes in calciregulatory hormone parathormone (PTH) were evaluated at the beginning of the study as well as at 5 and 12 months intervals. Blood levels of vitamin D, vitamin C, Ca, Mg and the lipid profile were assessed at the beginning and at the end of the study. Anthropometric indices (weight, body fat(Kg), Body Mass Index(BMI) and bone mineral density(BMD) were evaluated at the beginning and at the end of the study.
Interventions
OTHERFunctional olive paste
Homogenised olive pastes, enriched with mountain tea, were supplied by two ac-credited Greek olive oil and olive products companies, Arcadian Taste and GAEA. The fortified olive pastes, contained 7.5 g of extra virgin olive oil, 3.75 g of salt, 3.75 g of grated oregano, 3.75 g of grated pepper, 7.5 g of grated garlic, 6.25 g of orange juice, 65 g of Kala-mon olives without seeds and 3 g of mountain tea and weighted 100 gr per portion size, as well.
OTHERCalciovitmag (CDCaMg)
Vitamin C (1000 mg), vitamin D3 (500 mg), Calcium (Ca) (500 mg ) and Magnesium (Mg) (300 mg)/day
OTHERPhosporovitmag (PDCaMg)
Bisphosphonates (150 mg), vitamin D3 (500 mg), Ca (500 mg ) and Mg (300 mg)/daily
OTHERControl
Vitamin D3 (500 mg), Calcium (500 mg) and Magnesium (300 mg)/daily
Sponsors
University of the Aegean
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
It was a single blinded nutritional intervention, where only participants didn't know in which group was recruited.
Intervention model description
Each study arm received different supplementation.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 45 to 75 years old * Screening for osteoporosis (t-score ≤ - 1 normal bone density, t-score ≤ 2.5 osteoporosis ) and osteopenia of the femur strength or spine (t-score between -1 and -2.5 )
Exclusion criteria
* Age \> 75 y.o. and \<45 y.o * Diagnosed with chronic diseases including cancer, diabetes, coronary heart disease and stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in calciregulatory hormone parathormone | 12 months | Changes in calciregulatory hormone parathormone (PTH) at baseline, 5 and 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Calcium | 12 months | Changes in Calcium at baseline and 12 months |
| Changes in Vitamin C | 12 months | Changes in Vitamin C at baseline and 12 months |
| Changes in Magnesium | 12 months | Changes in Magnesium at baseline and 12 months |
| Changes in Vitamin D | 12 months | Changes in Vitamin D at baseline and 12 months |
| Changes in body weight, body mass index and body fat | 12 months | Changes in body weight, body mass index and body fat at baseline and 12 months |
| Changes in Bone Mineral Density | 12 months | Changes in Bone Mineral Density at baseline and 12 months |
| Changes in serum lipids | 12 months | Changes in serum lipids at baseline and 12 months |
Countries
Greece
Outcome results
None listed