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NCT Number: NCT06135831

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

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.

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Key information

Conditions

Osteopenia or Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of the Aegean

Myrina, Limnos/Lesvos, 81 400, Greece

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional olive paste

Other

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

Calciovitmag (CDCaMg)

Other

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

Phosporovitmag (PDCaMg)

Other

Bisphosphonates (150 mg), vitamin D3 (500 mg), Ca (500 mg ) and Mg (300 mg)/daily

Other names: Bisphosphonates, Vitamin D, Calcium and Magnesium

Control

Other

Vitamin D3 (500 mg), Calcium (500 mg) and Magnesium (300 mg)/daily

Primary outcomes

  1. Changes in calciregulatory hormone parathormone

    Time frame: 12 months

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

Secondary outcomes

  1. Changes in Vitamin D

    Time frame: 12 months

    Changes in Vitamin D at baseline and 12 months

  2. Changes in Calcium

    Time frame: 12 months

    Changes in Calcium at baseline and 12 months

  3. Changes in Vitamin C

    Time frame: 12 months

    Changes in Vitamin C at baseline and 12 months

  4. Changes in Magnesium

    Time frame: 12 months

    Changes in Magnesium at baseline and 12 months

  5. Changes in serum lipids

    Time frame: 12 months

    Changes in serum lipids at baseline and 12 months

  6. Changes in body weight, body mass index and body fat

    Time frame: 12 months

    Changes in body weight, body mass index and body fat at baseline and 12 months

  7. Changes in Bone Mineral Density

    Time frame: 12 months

    Changes in Bone Mineral Density at baseline and 12 months

Sponsors and collaborators

Lead sponsor

University of the Aegean

Other

Registry information

Official study title

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

Acronym: Osteoporosis

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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