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.1 site in 1 country110 target enrollmentJuly 1, 2022

ConditionsMild Cognitive Impairment

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mild Cognitive Impairment
Sponsor: Biosearch S.A.
Enrollment: 110
Locations: 1
Primary Endpoint: Score of the Delayed Memory test.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2022

End Date

September 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biosearch S.A.

Responsible Party

Sponsor

Eligibility Criteria

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) ≥
•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).

Outcomes

Primary Outcomes

Score of the Delayed Memory test.

Time Frame: 6 months

Wechsler Memory Scale III questionnaire, delayed recall

Secondary Outcomes

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)