NCT06254040已完成不适用
Randomized, Triple-blind, Parallel-group Study to Evaluate the Effect of Consuming a Mixture of Extracts and DHA on the Mild Cognitive Impairment
Biosearch S.A.2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年7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
- 110
- 试验地点
- 2
- 主要终点
- Score of the Delayed Memory test.
研究概览
简要总结
The objective of this trial is to evaluate the effect of the consumption of a mixture of extracts and DHA on the mild cognitive impairment.
详细描述
According to the World Health Organization, around 50 million people in the world have dementia, so developing new strategies to prevent cognitive impairment is an important aspect.
Certain plant extracts have properties related to the improvement of brain function. In addition, adequate levels of DHA are essential for good cognitive functioning throughout the life cycle.
Therefore, the objective of this trial is to evaluate the effect of the consumption of a mixture of extracts and DHA on the mild cognitive impairment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women over 50 years of age at the time of the screening visit.
- •Mild cognitive impairment according to multidomain criteria.
- •Mini Mental State Examination (MMSE) ≥
- •Availability of an accompanying who is responsible for the patient taking the study product and attending visits.
- •Patients and accompanying who agree to sign the informed consent before performing any study procedure and after they have been informed about the methods and limitations of the study.
排除标准
- •Inability to perform neurocognitive tests.
- •Intake currently (or in the two weeks prior to the start the study) of nutraceuticals that may alter the results of the study: vitamin complexes, omega-3 supplements, omega-3 fortified foods, ginkgo supplements, or any other specific supplement for memory improvement.
- •Consumption of anti-dementia drugs such as memantine or cholinesterase inhibitors (ICE).
- •Consumption of benzodiazepines in unstable doses.
- •Severe psychiatric pathology.
- •Allergy to any of the ingredients of the study product or placebo (lactose intolerance, intolerance to milk protein or allergy to any of the extracts used).
结局指标
主要结局
Score of the Delayed Memory test.
时间窗: 6 months
Wechsler Memory Scale III questionnaire, delayed recall
次要结局
- Score of the Mini Mental State Examination test.(6 months)
- Analysis of plasma levels of interleukins IL-6 to inflammatory parameters.(6 months)
- Analysis of plasma levels of SAP to inflammatory parameters.(6 months)
- Score of the Immediate Memory test.(6 months)
- Analysis of plasma levels of insulin related to glucose metabolism.(6 months)
- Total score of the ADAS-cog neurocognitive test.(6 months)
- Analysis of plasma levels of interleukins IL-10 to inflammatory parameters.(6 months)
- Analysis of plasma levels of PTX3 to inflammatory parameters.(6 months)
- Analysis of plasma levels of glucose related to glucose metabolism.(6 months)
- Index of the HOMA IR(6 months)
- Analysis of plasma levels of interleukins IL-2 to inflammatory parameters.(6 months)
研究者
研究点 (2)
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