Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women. Effects Of Gluten-Free Diet And Physical Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Strength
研究概览
简要总结
Celiac disease (CD) is an immunological disorder that mainly affects the small intestine, generating an inflammatory process in response to the presence of gluten (a protein). Autoimmune diseases are part of a group of diseases that are difficult to diagnose without a specific protocol or consensus to detect them due to the number of symptoms and diseases with which it has a relationship. The incidence of CD in Spain -according to data from the rest of the European Economic Community, since there is no study on incidence in Spain- is assumed to be approximately 1 per 100 live births. It is more frequent in women, with a 2:1 ratio. The only treatment consists of a STRICT GLUTEN-FREE DIET FOR LIFE. This results in the disappearance of symptoms, normalization of serology and recovery of intestinal villi. Failure to follow the diet can lead to important complications which, especially in adulthood, can manifest themselves in the form of osteopenia, osteoporosis and a high risk of neoplasms in the digestive tract, mainly. The main objective is to achieve a physical and physiological improvement in menopausal or post-menopausal celiac women. The specific objectives will be to know the influence of a dietary-nutritional program combined with physical exercise in menopausal or post-menopausal celiac women on:
- Physical condition (strength, endurance, functional autonomy...).
- Body composition.
- Psychological aspects.
- Physiological parameters (heart rate, maximum oxygen consumption, blood analysis...).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Over 40 years old
- •Menopausal or post-menopausal women
- •Women with celiac disease (in the case of the experimental groups)
排除标准
- •Women of childbearing age
- •Women < 40 years old
- •Failure to sign informed consent form
结局指标
主要结局
Strength
时间窗: 12 weeks
A calibrated handgrip dynamometer (Takei 5101, Tokyo, Japan) measure isometric grip strength (HGS)
Functional autonomy test
时间窗: 12 weeks
GDLAM protocol
Creatinine in blood
时间窗: 12 weeks
Creatinine by blood test
Adherence to gluten-free diet
时间窗: 12 weeks
Questionnaire "Adherence to gluten-free diet" was performed.
Anthropometric assessment - Skinfolds
时间窗: 12 weeks
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Balance test
时间窗: 12 weeks
By means of the PSYMTEC® contact platform, which act as switches and are useful for recording contact times between supports.
Glucose in blood
时间窗: 12 weeks
Glucose by blood test
Body Composition - Lean Body Mass
时间窗: 12 weeks
Evaluation of lean body mass by bioimpedance.
Anthropometric assessment - Perimeters
时间窗: 12 weeks
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Anthropometric assessment - Height
时间窗: 12 weeks
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Resistance test
时间窗: 12 weeks
6-minute walk test. This test is an adaptation of the Rikli and Jones (1998) test.
Eating disorders
时间窗: 12 weeks
Eating disorders questionnaire: Eating Attitudes Test Questionnaire (EAT) in its 26-item version (EAT-26) in Spanish (Rivas et al., 2010).
Body Composition - Visceral Fat
时间窗: 12 weeks
Evaluation of visceral fat by bioimpedance.
Anthropometric assessment - Diameters
时间窗: 12 weeks
Restricted profile proposed by the International Society for the Development of Cineanthropometry was carried out.
Cholesterol in blood
时间窗: 12 weeks
Cholesterol by blood test
Urea in blood
时间窗: 12 weeks
Urea by blood test
Quality of Life (QoL)
时间窗: 12 weeks
A QoL questionnaire was performed; the WHOQOL-BREF of the World Health Organization
Body Composition - Fat Mass
时间窗: 12 weeks
Evaluation of body fat by bioimpedance.
Weight
时间窗: 12 weeks
Weight evaluation using a digital scale
State of mind
时间窗: 12 weeks
Evaluation by using the Profile of Mood States POMS questionnaire.
Heart rate variability
时间窗: 12 weeks
Using novel Firstbeat Bodyguard device (Föhr, 2016)
Maximum oxygen consumption
时间窗: 12 weeks
Heart rate measurement and recording with Firsbeat Bodyguard
次要结局
未报告次要终点
研究者
Prof. Dr. Alejandro Martínez-Rodríguez
Assistant Professor
University of Alicante