An interventional study of Functional olive paste and Calciovitmag (CDCaMg) in Osteopenia or Osteoporosis, sponsored by University of the Aegean. Completed at 1 site in Greece. Open to female participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by University of the Aegean · Not applicable, Interventional, and Other
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 115 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
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Exclusion Criteria:
Daily supplementation of diet with vitamin C (1000 mg), vitamin D3 (500 mg), calcium (Ca) (500 mg ) and magnesium (Mg) (300 mg)
Other: Calciovitmag (CDCaMg)
Daily supplementation of diet with vitamin D3 (500 mg), Ca (500 mg) and Mg (300 mg)
Other: Control
Daily supplementation of diet with bisphosphonates (150 mg), vitamin D3 (500 mg), Ca (500 mg ) and Mg (300 mg)
Other: Phosporovitmag (PDCaMg)
Daily supplementation of diet with 364 mg polyphenols via 50 g of an innovative functional food (Kalamata olive paste with mountain tea rich in polyphenols, (total phenolics 7,28±3.11 gallic acid/g) along with vitamin D3 (500 mg), Ca (500 mg) and Mg (300 mg)
Other: Functional 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.
Also known as: Olive paste enriched with mountain tea
Vitamin C (1000 mg), vitamin D3 (500 mg), Calcium (Ca) (500 mg ) and Magnesium (Mg) (300 mg)/day
Also known as: Vitamin C and D, Calcium and Magnesium
Bisphosphonates (150 mg), vitamin D3 (500 mg), Ca (500 mg ) and Mg (300 mg)/daily
Also known as: Bisphosphonates, Vitamin D, Calcium and Magnesium
Vitamin D3 (500 mg), Calcium (500 mg) and Magnesium (300 mg)/daily
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
Plan to share: No — No one individual participant data will be shared
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University of the Aegean