Bone Health, Osteoporosis
Conditions
Keywords
Mediterranean diet, resistance training, osteoporosis, aging, bone turnover markers, bone mineral density
Brief summary
This randomized controlled trial was designed to investigate the effects of progressive resistance training (PRT) combined with a Mediterranean diet on bone mineral density (BMD) and bone turnover markers (BTMs) in older adults. Participants underwent a detailed medical history assessment, clinical examination, and dietary evaluation. Individuals who met the inclusion criteria provided written informed consent prior to participation. All procedures were conducted in accordance with the Declaration of Helsinki, and the study protocol was approved by the Ethics Committee of Manouba University (no. C.S. ISSEP.KS N˚040/2024). Eligible participants were randomly allocated to either the experimental group (EXP; n = 22) or the control group (CON; n = 19). The intervention lasted 12 months. During this period, the EXP group participated in supervised PRT sessions combined with a Mediterranean diet intervention, while the CON group received no structured intervention.
Detailed description
Detailed Description This randomized controlled trial was conducted to examine the effects of progressive resistance training (PRT) combined with a Mediterranean diet on bone mineral density (BMD) and bone turnover markers (BTMs) in older adults. Participants were recruited and screened through a detailed medical history assessment, clinical examination, and dietary evaluation. Eligible individuals who met the inclusion criteria provided written informed consent before participation. Participants were randomly assigned to either the experimental group (EXP; n = 22) or the control group (CON; n = 19). The intervention lasted 12 months. During this period, the experimental group participated in supervised progressive resistance training sessions combined with a Mediterranean diet intervention, while the control group received no structured intervention and maintained their usual lifestyle. Bone mineral density and bone turnover markers were assessed at baseline and after the 12-month intervention period.
Interventions
BEHAVIORALMediterranean Diet combined with Resistance Training
Participants followed a Mediterranean diet and engaged in a supervised progressive resistance training program performed three times per week for 12 months. The training was progressively adapted based on individual capacity, focusing on major muscle groups using standard resistance exercises.
Sponsors
University of Sfax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
1\) an intervention group receiving both a Mediterranean diet and supervised progressive resistance training, and (2) a control group receiving no structured intervention.
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 65 years and older * Ability to provide written informed consent * Willingness to comply with study procedures and interventions * Capability to participate in a supervised exercise program
Exclusion criteria
* Presence of metabolic bone diseases (e.g., osteoporosis requiring pharmacological treatment, Paget's disease, osteomalacia) * Use of medications affecting bone metabolism, including systemic corticosteroids, bisphosphonates, hormone replacement therapy, selective estrogen receptor modulators, calcitonin, or parathyroid hormone analogs * Uncontrolled cardiometabolic or respiratory conditions (e.g., uncontrolled hypertension, unstable angina, recent cardiovascular events within 6 months, severe chronic obstructive pulmonary disease, or poorly controlled diabetes) * Severe musculoskeletal disorders or advanced osteoarthritis limiting safe exercise participation * Neurological or psychiatric conditions affecting mobility or adherence * Cognitive impairment (Mini-Mental State Examination score \<24) * Recent fractures or major orthopedic surgery within the past 12 months * Underweight (BMI \<18.5 kg/m²) or severe frailty * Severe renal or hepatic dysfunction (e.g., chronic kidney disease stage 4-5 or liver failure) * Active malignancy or ongoing chemotherapy/radiotherapy * Participation in another clinical trial within the previous 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Mineral Density (BMD) | Baseline and 12 months | Bone mineral density (BMD) was assessed using dual-energy X-ray absorptiometry (DXA) at the lumbar spine and femoral neck. Measurements were performed at baseline and after the 12-month intervention period. esults will be reported as BMD values expressed in g/cm². |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone Formation Markers | Baseline and 12 months | Bone formation marker, osteocalcin were assessed in fasting blood samples. Unit of Measure: ng/mL |
Countries
Italy
Outcome results
None listed