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

23 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

47

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Italien
    • LE
      • Lecce, LE, Italien, 73100
        • Antonella MUSCELLA

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Andra namn:
  • Mediterranean Diet and Supervised Resistance Training
Inget ingripande: Control Group
No Structured Intervention

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Bone Mineral Density (BMD)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Bone Formation Markers
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

University of Sfax

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 mars 2024

Primärt slutförande (Faktisk)

10 mars 2025

Avslutad studie (Faktisk)

10 mars 2025

Studieregistreringsdatum

Först inskickad

6 maj 2026

Först inskickad som uppfyllde QC-kriterierna

6 maj 2026

Första postat (Faktisk)

13 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • C.S. ISSEP.KS N˚040/2024

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