Mediterranean Diet and Progressive Resistance Training Effects on BMD and Bone Turnover in the Elderly (MED-RES-BONE)

May 23, 2026 updated by: Antonella Muscella, University of Sfax

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • LE
      • Lecce, LE, Italy, 73100
        • Antonella MUSCELLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mediterranean Diet + Progressive Resistance Training
Participants followed a Mediterranean diet combined with a supervised progressive resistance training program performed three times per week for 12 months.
Behavioral: Mediterranean 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.
Other Names:
  • Mediterranean Diet and Supervised Resistance Training
No Intervention: Control Group
No Structured Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Formation Markers
Time Frame: Baseline and 12 months
Bone formation marker, osteocalcin were assessed in fasting blood samples. Unit of Measure: ng/mL
Baseline and 12 months
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
Baseline and 12 months
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
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sfax

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

March 10, 2025

Study Completion (Actual)

March 10, 2025

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 23, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.S. ISSEP.KS N˚040/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoporosis

Clinical Trials on Mediterranean Diet combined with Resistance Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe