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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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LE
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Lecce、LE、意大利、73100
- Antonella MUSCELLA
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参与标准
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
其他名称：
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无干预：Control Group
No Structured Intervention
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Bone Mineral Density (BMD)
大体时间：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.
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Baseline and 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Bone Formation Markers
大体时间：Baseline and 12 months
|
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
大体时间：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
大体时间：Baseline and 12 months
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Fasting serum P1NP concentrations will be assessed as a marker of bone formation.
were assessed in fasting blood samples.
Unit of Measure: ng/mL
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Baseline and 12 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- C.S. ISSEP.KS N˚040/2024
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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