Skip to main content
OpenTrials
Completed

NCT Number: NCT07584785

Mediterranean Diet and Progressive Resistance Training Effects on BMD and Bone Turnover in the Elderly

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antonella MUSCELLA

Lecce, LE, 73100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Mediterranean Diet combined with Resistance Training

Behavioral

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.

Other names: Mediterranean Diet and Supervised Resistance Training

Primary outcomes

  1. Bone Mineral Density (BMD)

    Time frame: 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 outcomes

  1. Bone Formation Markers

    Time frame: Baseline and 12 months

    Bone formation marker, osteocalcin were assessed in fasting blood samples. Unit of Measure: ng/mL

  2. Bone Formation Markers

    Time frame: Baseline and 12 months

    Bone-specific alkaline phosphatase (BAP) were assessed in fasting blood samples. Unit of Measure: U/L

  3. Bone Formation Markers

    Time frame: Baseline and 12 months

    Fasting serum P1NP concentrations will be assessed as a marker of bone formation. were assessed in fasting blood samples. Unit of Measure: ng/mL

Sponsors and collaborators

Lead sponsor

University of Sfax

Other

Registry information

Official study title

Mediterranean Diet and Progressive Resistance Training Effects on BMD and Bone Turnover in Elderly

Acronym: MED-RES-BONE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 13, 2026
Registry last updated
May 28, 2026

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.

Published trials that share one or more normalized conditions with this study.