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

NCT06254040 | Completed

• 1 other identifier: C029
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

DHA; plant extracts; cognitive; brain

Outcome Measures

Primary Outcomes (1)

• Score of the Delayed Memory test.

  Wechsler Memory Scale III questionnaire, delayed recall

  6 months

Secondary Outcomes (11)

• Score of the Mini Mental State Examination test.

  6 months

• Score of the Immediate Memory test.

  6 months

• Total score of the ADAS-cog neurocognitive test.

  6 months

• Analysis of plasma levels of interleukins IL-6 to inflammatory parameters.

  6 months

• Analysis of plasma levels of interleukins IL-2 to inflammatory parameters.

  6 months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Volunteers will take 1 dissolving powder pack with maltodextrin daily for 6 months.

Dietary Supplement: Placebo

Experimental Group

EXPERIMENTAL

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

Interventions

Placebo DIETARY_SUPPLEMENT

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.

Control Group

mixture of extracts and DHA DIETARY_SUPPLEMENT

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 Group

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Biosearch S.A.: lead

Study Sites (1)

Complejo hospitalario Ruber Juan Bravo. Servicio de Neurología y Neurofisiología

Madrid, Madrid, 28006, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ruth Blanco Rojo, PhD

  Biosearch S.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: February 12, 2024
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: September 30, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)