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

University of Sfax

Status: Completed

Conditions: Osteoporosis; Bone Health

Treatments: Behavioral: Mediterranean Diet combined with Resistance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07584785

C.S. ISSEP.KS N˚040/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Mediterranean Diet + Progressive Resistance Training

Experimental group

Description:

Participants followed a Mediterranean diet combined with a supervised progressive resistance training program performed three times per week for 12 months.

Treatment:

Behavioral: Mediterranean Diet combined with Resistance Training

Control Group

No Intervention group

Description:

No Structured Intervention