Clinical trial NCT06135831: Effect of Consumption of Supplements and Enriched Olive Paste on Bone Metabolism Indices
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia or Osteoporosis
Keywords: postmenopausal
osteopenia
osteoporosis
supplements
functional olive paste
Lead sponsor: University of the Aegean
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 115
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each study arm received different supplementation.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in calciregulatory hormone parathormone
timeFrame: 12 months
Secondary outcomes:
measure: Changes in Vitamin D
timeFrame: 12 months
measure: Changes in Calcium
timeFrame: 12 months
measure: Changes in Vitamin C
timeFrame: 12 months
measure: Changes in Magnesium
timeFrame: 12 months
measure: Changes in serum lipids
timeFrame: 12 months
measure: Changes in body weight, body mass index and body fat
timeFrame: 12 months
measure: Changes in Bone Mineral Density
timeFrame: 12 months
Other outcomes:
Locations:
city: Myrina
country: Greece
facility: University of the Aegean
state: Limnos/Lesvos
Study officials:
References: