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.
: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
115
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.
Vitamin C (1000 mg), vitamin D3 (500 mg), Calcium (Ca) (500 mg ) and Magnesium (Mg) (300 mg)/day
Bisphosphonates (150 mg), vitamin D3 (500 mg), Ca (500 mg ) and Mg (300 mg)/daily
University of the Aegean
Myrina, Limnos/Lesvos, Greece
Changes in calciregulatory hormone parathormone
Changes in calciregulatory hormone parathormone (PTH) at baseline, 5 and 12 months
Time frame: 12 months
Changes in Vitamin D
Changes in Vitamin D at baseline and 12 months
Time frame: 12 months
Changes in Calcium
Changes in Calcium at baseline and 12 months
Time frame: 12 months
Changes in Vitamin C
Changes in Vitamin C at baseline and 12 months
Time frame: 12 months
Changes in Magnesium
Changes in Magnesium at baseline and 12 months
Time frame: 12 months
Changes in serum lipids
Changes in serum lipids at baseline and 12 months
Time frame: 12 months
Changes in body weight, body mass index and body fat
Changes in body weight, body mass index and body fat at baseline and 12 months
Time frame: 12 months
Changes in Bone Mineral Density
Changes in Bone Mineral Density at baseline and 12 months
Time frame: 12 months
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Vitamin D3 (500 mg), Calcium (500 mg) and Magnesium (300 mg)/daily