Effect of Consumption of Supplements and Enriched Olive Paste on Bone Metabolism Indices

Study Overview
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Brief Summary
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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
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: 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.

Official Title
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Effect of the Consumption of Vitamin C, D3, Ca Supplements and Olive Paste Enriched With Mountain Tea on Bone Metabolism Indices in Postmenopausal Women With Increased Osteoporosis' Risk: A Prospective Interventional Study

Conditions
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Osteopenia or Osteoporosis

Intervention / Treatment
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* Other: Functional olive paste
* Other: Calciovitmag (CDCaMg)
* Other: Phosporovitmag (PDCaMg)
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each study arm received different supplementation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calciovitmag (CDCaMg)<br>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)<br>* Vitamin C (1000 mg), vitamin D3 (500 mg), Calcium (Ca) (500 mg ) and Magnesium (Mg) (300 mg)/day<br>* Other names: Vitamin C and D, Calcium and Magnesium;|
| Placebo Comparator: Control<br>Daily supplementation of diet with vitamin D3 (500 mg), Ca (500 mg) and Mg (300 mg) | Other: Control<br>* Vitamin D3 (500 mg), Calcium (500 mg) and Magnesium (300 mg)/daily<br>|
| Experimental: Phosphorovitmag (PDCaMg)<br>Daily supplementation of diet with bisphosphonates (150 mg), vitamin D3 (500 mg), Ca (500 mg ) and Mg (300 mg) | Other: Phosporovitmag (PDCaMg)<br>* Bisphosphonates (150 mg), vitamin D3 (500 mg), Ca (500 mg ) and Mg (300 mg)/daily<br>* Other names: Bisphosphonates, Vitamin D, Calcium and Magnesium;|
| Experimental: Functional Olive paste<br>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<br>* 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.<br>* Other names: Olive paste enriched with mountain tea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in calciregulatory hormone parathormone | Changes in calciregulatory hormone parathormone (PTH) at baseline, 5 and 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Vitamin D | Changes in Vitamin D at baseline and 12 months | 12 months | 
| Changes in Calcium | Changes in Calcium at baseline and 12 months | 12 months | 
| Changes in Vitamin C | Changes in Vitamin C at baseline and 12 months | 12 months | 
| Changes in Magnesium | Changes in Magnesium at baseline and 12 months | 12 months | 
| Changes in serum lipids | Changes in serum lipids at baseline and 12 months | 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 | 12 months | 
| Changes in Bone Mineral Density | Changes in Bone Mineral Density at baseline and 12 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postmenopausal, osteopenia, osteoporosis, supplements, functional olive paste