NCT06743841已完成不适用
Study of the Efficacy of a New Nutritional Supplement, Compared with Placebo, in Promoting Active and Healthy Aging from the Age of 65
Clinica Universidad de Navarra, Universidad de Navarra2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Nutritional score.
研究概览
简要总结
The main aim of this clinical trial is to learn if a nutritional supplement improves health status from a nutritional point of view in an active and healthy elderly population. It will also study about the improvement of anthropometric variables, vitality, quality of life and mood, as well as biochemical and metabolic changes produced after the intervention.
The main questions it aims to answer are:
- Does a nutritional supplement improve the general nutritional status?
- What health parameters improve most clearly after taking the supplement? Researchers will compare a nutritional supplement to a placebo (a look-alike substance that contains no interest nutrients) to see if the nutritional supplement works to improve health status from a nutritional point of view.
Participants will:
- Take a nutritional supplement or a placebo every day for 8 weeks.
- Visit the clinic once every 4 weeks for checkups and tests
- Keep a diary of their symptoms and the degree of adherence to taking the nutritional supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between 65 and 80 years of age, inclusive.
- •Body mass index (BMI) less than 35 kg/m
- •Subjects must have a cultural level, general physical and psychological conditions that allow the understanding, monitoring and development of the study.
- •Agree to voluntarily participate in the study and provide their informed consent in writing, complying with the procedures and requirements of the study.
排除标准
- •People allergic to soy or lactose, as the supplement contains traces.
- •Severe diseases or relevant functional or structural abnormalities of the digestive system: inflammatory bowel disease.
- •Surgical interventions of the digestive system with permanent sequelae such as resections (gastroduodenostomy...)
- •Presenting any type of serious or chronic or systemic disease such as: infections that cause impairment of the general condition, cardiovascular diseases, cardiac arrhythmias, stroke, neoplasia, severe kidney disease, liver disease...
- •Recent fracture in the last 3 months (strength training).
- •Subjects who present some type of cognitive and/or psychological impediment, Alzheimer's, depressive pathology, etc.
- •Pharmacological treatment that affects the study variables recently prescribed, without a stable dose prescribed.
- •People with diabetes of any type.
- •Intake of any type of nutritional supplement that includes vitamin D, folic acid, vitamin B6, vitamin B12, calcium, iron, zinc or proteins, in the last 3 months.
- •Being on any type of special diet and/or high alcohol consumption (more than 14 units in women and 20 units in men per week).
- •Subjects in whom poor collaboration is expected or who, in the opinion of the researcher, have difficulties in following the procedures of the study.
- •Lack of commitment (in the opinion of the researcher) to the intervention, suspicion of non-compliance, or real difficulties in following the development of the study.
结局指标
主要结局
Nutritional score.
时间窗: Days 0 and 56
A nutritional score was created ad hoc to estimate the effects of a nutritional supplement . The parameters included in the score were: muscle mass, lymphocyte level, protein status, vitamin D, folic acid, vitamin B12, calcium, iron, zinc, and homocysteine levels
次要结局
- Dietary intake(Days 0 and 56)
- Height(Days 0 and 56)
- Weight(Days 0 and 56)
- Waist circumference(Days 0 and 56)
- Hip circumference(Days 0 and 56)
- Total adipose tissue(Days 0 and 56)
- Visceral adipose tissue(Days 0 and 56)
- Lean mass(Days 0 and 56)
- Upper limb strength(Days 0 and 56)
- Lower limb strength(Days 0 and 56)
- Maximum hand grip(Days 0 and 56)
- Blood fasting glucose(Days 0 and 56)
- Blood fasting insulin(Days 0 and 56)
- Total cholesterol(Days 0 and 56)
- HDL-cholesterol(Days 0 and 56)
- LDL-cholesterol(Days 0 and 56)
- Triglycerides(Days 0 and 56)
- C-Reactive Protein(Days 0 and 56)
- Interleukin 6(Days 0 and 56)
- Tumor necrosis factor -α(Days 0 and 56)
- Blood pressure(Days 0 and 56)
- Depression level(Days 0 and 56)
- Anxiety level(Days 0 and 56)
- Short Form-36 questionnaire(Days 0 and 56)
研究者
研究点 (2)
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