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

NCT07584785 | Completed

• 1 other identifier: C.S. ISSEP.KS N˚040/2024
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Health; Osteoporosis

Keywords

Mediterranean diet; resistance training; osteoporosis; aging; bone turnover markers; bone mineral density

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density (BMD)

  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.

  Baseline and 12 months

Secondary Outcomes (1)

• Bone Formation Markers

  Baseline and 12 months

Study Arms (2)

Mediterranean Diet + Progressive Resistance Training

EXPERIMENTAL

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

Control Group

NO INTERVENTION

No Structured Intervention

Interventions

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.

Also known as: Mediterranean Diet and Supervised Resistance Training

Mediterranean Diet + Progressive Resistance Training

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sfax: lead

Study Sites (1)

Antonella MUSCELLA

Lecce, LE, 73100, Italy

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Resistance Training; Diet, Mediterranean

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Sport Sciences

Model Details: Participants were assigned to two parallel groups: 1. Mediterranean diet combined with progressive resistance training, and 2. control group receiving no structured intervention.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 13, 2026
• Study Start: March 1, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

IT (1)