Evaluación Del Efecto de la Ingesta de Una Barrita Con Alto Contenido de proteína Sobre el Peso y la Salud Osteoarticular
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Change in fat mass
研究概览
简要总结
The goal of this intervention study is to evaluate the efficacy in subjects with overweight or obesity of protein bars consumption. The main questions it aims to answer are:
- Does the regular consumption of these protein bars help to loose weight?
- Does the regular consumption of these protein bars help to improve the osteoarticular health? Participants will be asked to follow the indications of consumption of the bars togather with healthy nutritional advice during 16 weeks.
Researchers will compare exparimental Versus placebo groups to see if weight is lost in similar or different ways.
详细描述
The intervention is designed to evaluate the efficacy of the consumption of a protein bar vs placebo on weight control and osteoarticular health.
For this purpose, a total of 102 subjects will be randomised to either the experimental group or the placebo group, the only stratification performed will be acording to sex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 25 and 37.5 kg/m2
- •Normal physical examination and vital signs according to clinical examiners.
- •Chronic pharmacological treatment is permitted if dosage is stable within at least three months prior the start of the intervention.
排除标准
- •Any funcitonal or structural impairment in digestive system (hitus hernia, ulcers, inflammatory bowel disease, etc.)
- •Excessive alcohol consumption (> 14 units/week in women and > 20 units per week in men)
- •Bariatric surgery or similar
- •Arthritis, hepatic diseases, cancer.
- •Alergy to any component of the products
- •Subjects presenting any cognitive or psichiatric impairment, that may impel them to follow the protocol.
- •Subjects following any weight loss program
结局指标
主要结局
Change in fat mass
时间窗: 16 weeks
Body composition . Change in fat mass between baseline and end of intervention
Ponderal evolution
时间窗: 16 weeks
Change in body weight between baseline and end of intervention
Change in fat-free mass
时间窗: 16 weeks
Body composition . Change in fat-free mass between baseline and end of intervention
次要结局
- Osteoarticular changes(16 weeks)
- Plasma P2P and CTX-II levels(16 weeks)
研究者
Santiago Navas
Principal Investigator
University of Navarra