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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of the Aegean
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Changes in calciregulatory hormone parathormone
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Masking Description
It was a single blinded nutritional intervention, where only participants didn't know in which group was recruited.
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Calciovitmag (CDCaMg)
Daily supplementation of diet with vitamin C (1000 mg), vitamin D3 (500 mg), calcium (Ca) (500 mg ) and magnesium (Mg) (300 mg)
Intervention: Calciovitmag (CDCaMg) (Other)
Control
Daily supplementation of diet with vitamin D3 (500 mg), Ca (500 mg) and Mg (300 mg)
Intervention: Control (Other)
Phosphorovitmag (PDCaMg)
Daily supplementation of diet with bisphosphonates (150 mg), vitamin D3 (500 mg), Ca (500 mg ) and Mg (300 mg)
Intervention: Phosporovitmag (PDCaMg) (Other)
Functional Olive paste
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)
Intervention: Functional olive paste (Other)
Outcomes
Primary Outcomes
Changes in calciregulatory hormone parathormone
Time Frame: 12 months
Changes in calciregulatory hormone parathormone (PTH) at baseline, 5 and 12 months
Secondary Outcomes
- Changes in Vitamin C(12 months)
- Changes in Vitamin D(12 months)
- Changes in Bone Mineral Density(12 months)
- Changes in Calcium(12 months)
- Changes in serum lipids(12 months)
- Changes in body weight, body mass index and body fat(12 months)
- Changes in Magnesium(12 months)