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

NCT06135831 | Completed

• 1 other identifier: Osteo21
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia or Osteoporosis

Keywords

postmenopausal; osteopenia; osteoporosis; supplements; functional olive paste

Outcome Measures

Primary Outcomes (1)

• Changes in calciregulatory hormone parathormone

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

  12 months

Secondary Outcomes (7)

• Changes in Vitamin D

  12 months

• Changes in Calcium

  12 months

• Changes in Vitamin C

  12 months

• Changes in Magnesium

  12 months

• Changes in serum lipids

  12 months

Study Arms (4)

Calciovitmag (CDCaMg)

EXPERIMENTAL

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)

Control

PLACEBO COMPARATOR

Daily supplementation of diet with vitamin D3 (500 mg), Ca (500 mg) and Mg (300 mg)

Other: Control

Phosphorovitmag (PDCaMg)

EXPERIMENTAL

Daily supplementation of diet with bisphosphonates (150 mg), vitamin D3 (500 mg), Ca (500 mg ) and Mg (300 mg)

Other: Phosporovitmag (PDCaMg)

Functional Olive paste

EXPERIMENTAL

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

Interventions

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.

Also known as: Olive paste enriched with mountain tea

Functional Olive paste

Calciovitmag (CDCaMg) OTHER

Vitamin C (1000 mg), vitamin D3 (500 mg), Calcium (Ca) (500 mg ) and Magnesium (Mg) (300 mg)/day

Also known as: Vitamin C and D, Calcium and Magnesium

Calciovitmag (CDCaMg)

Phosporovitmag (PDCaMg) OTHER

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

Also known as: Bisphosphonates, Vitamin D, Calcium and Magnesium

Phosphorovitmag (PDCaMg)

Control OTHER

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

Control

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Only postmenopausal women with osteopenia or osteoporosis were eligible for participation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )

You may not qualify if:

• Age \> 75 y.o. and \<45 y.o
• Diagnosed with chronic diseases including cancer, diabetes, coronary heart disease and stroke

Sponsors & Collaborators

• University of the Aegean: lead

Study Sites (1)

University of the Aegean

Myrina, Limnos/Lesvos, 81 400, Greece

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Interventions

Ascorbic Acid; Fumigant 93; Calcium; Magnesium; Diphosphonates; Vitamin D

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Metals, Light; Organophosphonates; Organophosphorus Compounds; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It was a single blinded nutritional intervention, where only participants didn't know in which group was recruited.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each study arm received different supplementation.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: March 15, 2019
• Primary Completion: June 15, 2021
• Study Completion: June 30, 2021
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)