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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Volunteers will take 1 dissolving powder pack with maltodextrin daily for 6 months. |
|
| Experimental Group | Experimental | Volunteers will take 1 dissolving powder pack with the mixture of extracts and DHA daily for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Each participant will consume 1 dissolving powder pack per day diluted in water, with breakfast, without any restriction in the diet or in their life habits. |
| Measure | Description | Time Frame |
|---|---|---|
| Score of the Delayed Memory test. | Wechsler Memory Scale III questionnaire, delayed recall | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Score of the Mini Mental State Examination test. | Total score obtained in tests of: orientation, fixation, calculation and attention, memory, language and construction. | 6 months |
| Score of the Immediate Memory test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Blanco Rojo, PhD | Biosearch S.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo hospitalario Ruber Juan Bravo. Servicio de NeurologÃa y NeurofisiologÃa | Madrid | Madrid | 28006 | Spain |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| mixture of extracts and DHA | Dietary Supplement | Each participant will consume 1 dissolving powder pack per day diluted in water, with breakfast, without any restriction in the diet or in their life habits. |
|
Wechsler Memory Scale III questionnaire, immediate recall.
| 6 months |
| Total score of the ADAS-cog neurocognitive test. | Total score obtained in tests of: word recall, commands, object and finger naming, constructive praxis, ideational praxis, orientation, word recognition, memory test instruction recall, spoken language ability, spoken language comprehension, difficulty finding the right words. | 6 months |
| Analysis of plasma levels of interleukins IL-6 to inflammatory parameters. | Levels of interleukins IL-6 | 6 months |
| Analysis of plasma levels of interleukins IL-2 to inflammatory parameters. | Levels of interleukins IL-2 | 6 months |
| Analysis of plasma levels of interleukins IL-10 to inflammatory parameters. | Levels of interleukins IL-10 | 6 months |
| Analysis of plasma levels of PTX3 to inflammatory parameters. | Levels of PTX3 | 6 months |
| Analysis of plasma levels of SAP to inflammatory parameters. | Levels of SAP. | 6 months |
| Analysis of plasma levels of glucose related to glucose metabolism. | Levels of glucose | 6 months |
| Analysis of plasma levels of insulin related to glucose metabolism. | Levels of insulin | 6 months |
| Index of the HOMA IR | Index of the HOMA IR | 6 months |