Clinical trial NCT06254040: Effect of Consuming a Mixture of Extracts and DHA on the Mild Cognitive Impairment
Official title: Randomized, Triple-blind, Parallel-group Study to Evaluate the Effect of Consuming a Mixture of Extracts and DHA on the Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: DHA
plant extracts
cognitive
brain
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2024-02-12
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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) ≥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).

Primary outcomes:
measure: Score of the Delayed Memory test.
timeFrame: 6 months
Secondary outcomes:
measure: Score of the Mini Mental State Examination test.
timeFrame: 6 months
measure: Score of the Immediate Memory test.
timeFrame: 6 months
measure: Total score of the ADAS-cog neurocognitive test.
timeFrame: 6 months
measure: Analysis of plasma levels of interleukins IL-6 to inflammatory parameters.
timeFrame: 6 months
measure: Analysis of plasma levels of interleukins IL-2 to inflammatory parameters.
timeFrame: 6 months
measure: Analysis of plasma levels of interleukins IL-10 to inflammatory parameters.
timeFrame: 6 months
measure: Analysis of plasma levels of PTX3 to inflammatory parameters.
timeFrame: 6 months
measure: Analysis of plasma levels of SAP to inflammatory parameters.
timeFrame: 6 months
measure: Analysis of plasma levels of glucose related to glucose metabolism.
timeFrame: 6 months
measure: Analysis of plasma levels of insulin related to glucose metabolism.
timeFrame: 6 months
measure: Index of the HOMA IR
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Complejo hospitalario Ruber Juan Bravo. Servicio de Neurología y Neurofisiología
Study officials:
affiliation: Biosearch S.A.
name: Ruth Blanco Rojo, PhD
role: PRINCIPAL_INVESTIGATOR
References: