Mediterranean Diet and Progressive Resistance Training Effects on BMD and Bone Turnover in Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Bone Mineral Density (BMD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control Group
No Structured Intervention
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.
干预措施: Mediterranean Diet combined with Resistance Training (Behavioral)
结局指标
主要结局
Bone Mineral Density (BMD)
时间窗: 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.
次要结局
- Bone Formation Markers(Baseline and 12 months)
研究者
Antonella Muscella
Associate Professor of Sport Sciences
University of Sfax