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

Not Applicable

Completed

• Conditions: Osteopenia or Osteoporosis

• Registration Number: NCT06135831
• Lead Sponsor: University of the Aegean

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 Timeline

• Study Start: 2019-03-15
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-30
• Status Verified: 2023-11
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-16
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in calciregulatory hormone parathormone	12 months	Changes in calciregulatory hormone parathormone (PTH) at baseline, 5 and 12 months

Secondary Outcome Measures

Name	Time	Method
Changes in Vitamin D	12 months	Changes in Vitamin D 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
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 Magnesium	12 months	Changes in Magnesium at baseline and 12 months
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

Trial Locations

Locations (1)

University of the Aegean; 🇬🇷 Myrina, Limnos/Lesvos, Greece