Mediterranean Diet and Progressive Resistance Training Effects on BMD and Bone Turnover in the Elderly (MED-RES-BONE)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
LE
-
Lecce, LE, Italien, 73100
- Antonella MUSCELLA
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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.
Andre navne:
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Ingen indgriben: Control Group
No Structured Intervention
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Bone Mineral Density (BMD)
Tidsramme: Baseline and 12 months
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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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Bone Formation Markers
Tidsramme: Baseline and 12 months
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Bone formation marker, osteocalcin were assessed in fasting blood samples.
Unit of Measure: ng/mL
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Baseline and 12 months
|
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Bone Formation Markers
Tidsramme: Baseline and 12 months
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Bone-specific alkaline phosphatase (BAP) were assessed in fasting blood samples.
Unit of Measure: U/L
|
Baseline and 12 months
|
|
Bone Formation Markers
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Knoglesygdomme
- Muskuloskeletale sygdomme
- Metaboliske sygdomme
- Knoglesygdomme, metaboliske
- Ernæringsmæssige og metaboliske sygdomme
- Osteoporose
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Terapeutik
- Fysioterapimodaliteter
- Diæt, mad og ernæring
- Fysiologiske fænomener
- Ernæringsfysiologiske fænomener
- Patientpleje
- Træningsterapi
- Rehabilitering
- Efterpleje
- Kontinuitet i patientpleje
- Diæt, plantebaseret
- Diætterapi
- Ernæringsterapi
- Kost
- Fysisk konditionering, menneske
- Øvelse
- Diæt, Middelhavet
- Modstandstræning
Andre undersøgelses-id-numre
- C.S. ISSEP.KS N˚040/2024
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