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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia or Osteoporosis
• Intervention / Treatment: Other: Calciovitmag (CDCaMg); Other: Control; Other: Phosporovitmag (PDCaMg); Other: Functional olive paste

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 Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Limnos/Lesvos
    • Myrina, Limnos/Lesvos, Greece, 81 400
      • University of the Aegean

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of the Aegean

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: osteoporosis; postmenopausal; supplements; osteopenia; functional olive paste
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Osteoporosis; Bone Diseases, Metabolic; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium; Vitamins; Calcium, Dietary; Diphosphonates
• Other Study ID Numbers: Osteo21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No one individual participant data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No