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

Randomized, Triple-blind, Parallel-group Study to Evaluate the Effect of Consuming a Mixture of Extracts and DHA on the Mild Cognitive Impairment

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 Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: mixture of extracts and DHA

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28006
    • Complejo hospitalario Ruber Juan Bravo. Servicio de Neurología y Neurofisiología

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Volunteers will take 1 dissolving powder pack with maltodextrin daily for 6 months.	Dietary supplement: Placebo; 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.
Experimental: Experimental Group; Volunteers will take 1 dissolving powder pack with the mixture of extracts and DHA daily for 6 months.	Dietary supplement: mixture 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of the Delayed Memory test.	Wechsler Memory Scale III questionnaire, delayed recall	6 months

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Investigators: Principal Investigator: Ruth Blanco Rojo, PhD, Biosearch S.A.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: DHA; brain; cognitive; plant extracts
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: C029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No