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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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LE
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Lecce, LE, Italien, 73100
- Antonella MUSCELLA
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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.
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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.
Andere Namen:
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Kein Eingriff: Control Group
No Structured Intervention
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Bone Mineral Density (BMD)
Zeitfenster: 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.
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Baseline and 12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Bone Formation Markers
Zeitfenster: 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
Zeitfenster: Baseline and 12 months
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Bone-specific alkaline phosphatase (BAP) were assessed in fasting blood samples.
Unit of Measure: U/L
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Baseline and 12 months
|
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Bone Formation Markers
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Knochenerkrankungen
- Erkrankungen des Bewegungsapparates
- Stoffwechselerkrankungen
- Knochenerkrankungen, Stoffwechsel
- Ernährungs- und Stoffwechselerkrankungen
- Osteoporose
- Motorik
- Bewegung
- Phänomen des Bewegungsapparates muskuloskelettal
- Muskuloskelettaler und neuronales physiologisches Phänomen
- Therapeutika
- Physiotherapiemodalitäten
- Ernährung, Nahrung und Ernährung
- Physiologische Phänomene
- Ernährung physiologische Phänomene
- Patientenversorgung
- Trainingstherapie
- Rehabilitation
- Nachbehandlung
- Kontinuität der Patientenversorgung
- Diät, pflanzlicher Basis
- Diättherapie
- Ernährungstherapie
- Diät
- Körperliche Kondition, menschlich
- Übung
- Diät, Mittelmeer
- Widerstandstraining
Andere Studien-ID-Nummern
- C.S. ISSEP.KS N˚040/2024
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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