NCT05472285已完成不适用
Evaluation of the Effects of a Food Supplementation on the Improvement of Cognitive Functions in Healthy Seniors: a Randomized Double-blind Study Versus Placebo
Robertet SA4 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2022年5月23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
- 144
- 试验地点
- 4
- 主要终点
- The change in mental fatigue
研究概览
简要总结
The hypothesis of this study is to evaluate the effect of supplementation for 8 weeks on the improvement of cognitive functions in healthy seniors with or without mild cognitive decline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 55 and 70 years (limits included),
- •Subjects with mild cognitive decline (MMSE between 21 and 24, including bounds) and healthy (MMSE >24 to 30).
- •Subject with a Hamilton Anxiety Scale score between 5 and 17 (limits included),
- •BMI between 18.5 and 29.5 kg/m² (limits included),
- •Menopausal woman without hormone replacement therapy (at least 12 months without menstruation),
- •Stable diet for at least 3 months,
- •Blood pressure below 14/90 mm HG,
- •With no significant change in dietary habits or physical activity during the 3 months preceding randomization and agreeing to maintain them unchanged throughout the study,
- •Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,
- •Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
- •Affiliated with a social security scheme,
- •Agree to be registered on the volunteers in biomedical research file.
排除标准
- •Suffering from a metabolic disorder such as diabetes treated or not, uncontrolled thyroidal trouble or other metabolic disorder,
- •Suffering from a serious chronic disease (cancer (ongoing and if in remission for less than 5 years), HIV, renal failure, ongoing biliary or liver disorder, psychiatric pathologies (bi-polar disorders, depression, degenerative brain diseases (Alzheimer, vascular dementia, etc.), immunodeficiency, uncontrolled heart disease, arthritis, chronic respiratory disorder, chronic inflammatory digestive disease or a gastrointestinal disorder deemed incompatible with driving the vehicle. ), immunodeficiency, uncontrolled heart disease, arthritis, chronic respiratory disorder, chronic inflammatory digestive disease or a gastrointestinal disorder deemed incompatible with the conduct of the study by the investigator (e.g. celiac disease, Crohn's disease, irritable bowel disease, etc.).
- •For Women: Non-menopausal woman or menopausal woman with hormone replacement therapy
- •Consuming more than 5 cigarettes per day,
- •With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient,
- •Under antioxidant treatment (vitamin A, C, E, β-carotene, lutein, lycopene, selenium, Ginkgo biloba, dehydroepiandrosterone, polyphenol in the broad sense, phytoestrogen, ...), sedative drugs (neuroleptics, benzodiazepines, anxiolytics, hypnotics) and related drugs, antidepressants, antipsychotics, mood stabilizers, (hypnotic anti-histamines... ), cognitive treatment or dietary supplements that could affect the parameters monitored during the study in the opinion of the investigator or in the month preceding the V1 visit.
- •Volunteer consuming no more than 400mg/d of total caffeine in a day (addition of beverages such as coffee, tea, energy drinks and soft drinks), [6 espressos = 162mg of caffeine and 4 mugs of filter coffee = 380mg, 8 cups of black tea = 360mg].
- •Having a consumption of herbal infusions or waters > 2 liters / day
- •Presenting a high probability of non-compliance with the protocol or of dropping out during the study (geographical instability, insufficient motivation, psychological profile, etc),
- •Drinking more than 2 glasses of alcohol per day, every day and without interruption, and not willing to keep their drinking habits unchanged throughout the study
- •Taking part in another clinical trial or being in the exclusion period of a previous clinical trial
- •Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros,
- •Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
- •Presenting a psychological or linguistic incapability to sign the informed consent,
- •Impossible to contact in case of emergency.
结局指标
主要结局
The change in mental fatigue
时间窗: up to 10 weeks
Mental fatigue is assessed twice on a VAS (Visual Analogue Scale) in the COMPASS test, which is a computerized test assessing cognitive functions. The first VAS is assessed following the cognitive Demand Battery comprising 3 tasks, namely a 3s serial subtraction task, a 7s serial subtraction task and another COMPASS task called Digit vigilance.
次要结局
- Evolution of global cognitive functioning(up to 10 weeks)
- Evolution of cognitive function(up to 10 weeks)
- The frequency of adverse events(up to 10 weeks)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer CachexiaWeight LossGastrointestinal CancerLung CancerCancer CachexiaNCT04131426University of Rochester25
已完成
不适用
Ideal food for severely malnourished HIV childreCTRI/2016/03/006774Rotary Club Aurangabad and Mahim Mumbai100
已完成
不适用
An Exploratory Investigation of Dietary Supplementation and Its EffectQuality of LifeNCT05037877HUM Nutrition, Inc.110
尚未招募
4 期
The Impact of Nutritional Optimization to Enhance Post-operative Outcomes Using the R-Support SupplementsAbdominoplastyBreast ReductionAutologous Breast ReconstructionBody Contouring SurgeryNCT06601868Universitair Ziekenhuis Brussel200
Unknown
不适用
Hericium Erinaceus Mycelium and Probiotic of the Grape King Bio on Symptoms of Premenstrual SyndromePremenstrual SyndromeNCT05443477Chung Shan Medical University105