Effect of Consuming a Mixture of Extracts and DHA on the Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Dietary Supplement: mixture of extracts and DHA; Dietary Supplement: Placebo

• Registration Number: NCT06254040
• Lead Sponsor: Biosearch S.A.

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-08-24
• Primary Completion: 2023-07-01
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-12
• Study Completion: 2024-09-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	mixture of extracts and DHA	Volunteers will take 1 dissolving powder pack with the mixture of extracts and DHA daily for 6 months.
Control Group	Placebo	Volunteers will take 1 dissolving powder pack with maltodextrin daily for 6 months.

Primary Outcome Measures

Name	Time	Method
Score of the Delayed Memory test.	6 months	Wechsler Memory Scale III questionnaire, delayed recall

Secondary Outcome Measures

Name	Time	Method
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.
Analysis of plasma levels of interleukins IL-6 to inflammatory parameters.	6 months	Levels of interleukins IL-6
Analysis of plasma levels of SAP to inflammatory parameters.	6 months	Levels of SAP.
Score of the Immediate Memory test.	6 months	Wechsler Memory Scale III questionnaire, immediate recall.
Analysis of plasma levels of insulin related to glucose metabolism.	6 months	Levels of insulin
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 interleukins IL-10 to inflammatory parameters.	6 months	Levels of interleukins IL-10
Analysis of plasma levels of PTX3 to inflammatory parameters.	6 months	Levels of PTX3
Analysis of plasma levels of glucose related to glucose metabolism.	6 months	Levels of glucose
Index of the HOMA IR	6 months	Index of the HOMA IR
Analysis of plasma levels of interleukins IL-2 to inflammatory parameters.	6 months	Levels of interleukins IL-2

Trial Locations

Locations (1)

Complejo hospitalario Ruber Juan Bravo. Servicio de Neurología y Neurofisiología; 🇪🇸 Madrid, Spain