Mild Cognitive Impairment
Conditions
Keywords
DHA, plant extracts, cognitive, brain
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
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.
DIETARY_SUPPLEMENTmixture of extracts and DHA
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.
Sponsors
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* 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) ≥21. * 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score of the Delayed Memory test. | 6 months | Wechsler Memory Scale III questionnaire, delayed recall |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score of the Mini Mental State Examination test. | 6 months | Total score obtained in tests of: orientation, fixation, calculation and attention, memory, language and construction. |
| Score of the Immediate Memory test. | 6 months | Wechsler Memory Scale III questionnaire, immediate recall. |
| Analysis of plasma levels of interleukins IL-6 to inflammatory parameters. | 6 months | Levels of interleukins IL-6 |
| Analysis of plasma levels of interleukins IL-2 to inflammatory parameters. | 6 months | Levels of interleukins IL-2 |
| Analysis of plasma levels of interleukins IL-10 to inflammatory parameters. | 6 months | Levels of interleukins IL-10 |
| Total score of the ADAS-cog neurocognitive test. | 6 months | 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. |
| Analysis of plasma levels of SAP to inflammatory parameters. | 6 months | Levels of SAP. |
| Analysis of plasma levels of glucose related to glucose metabolism. | 6 months | Levels of glucose |
| Analysis of plasma levels of insulin related to glucose metabolism. | 6 months | Levels of insulin |
| Index of the HOMA IR | 6 months | Index of the HOMA IR |
| Analysis of plasma levels of PTX3 to inflammatory parameters. | 6 months | Levels of PTX3 |
Countries
Spain
Outcome results
None listed