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Completed

NCT Number: NCT06254040

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.

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Key information

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complejo hospitalario Ruber Juan Bravo. Servicio de Neurología y Neurofisiología

Madrid, 28006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Score of the Delayed Memory test.

    Time frame: 6 months

    Wechsler Memory Scale III questionnaire, delayed recall

Secondary outcomes

  1. Score of the Mini Mental State Examination test.

    Time frame: 6 months

    Total score obtained in tests of: orientation, fixation, calculation and attention, memory, language and construction.

  2. Score of the Immediate Memory test.

    Time frame: 6 months

    Wechsler Memory Scale III questionnaire, immediate recall.

  3. Total score of the ADAS-cog neurocognitive test.

    Time frame: 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.

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

    Time frame: 6 months

    Levels of interleukins IL-6

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

    Time frame: 6 months

    Levels of interleukins IL-2

  6. Analysis of plasma levels of interleukins IL-10 to inflammatory parameters.

    Time frame: 6 months

    Levels of interleukins IL-10

  7. Analysis of plasma levels of PTX3 to inflammatory parameters.

    Time frame: 6 months

    Levels of PTX3

  8. Analysis of plasma levels of SAP to inflammatory parameters.

    Time frame: 6 months

    Levels of SAP.

  9. Analysis of plasma levels of glucose related to glucose metabolism.

    Time frame: 6 months

    Levels of glucose

  10. Analysis of plasma levels of insulin related to glucose metabolism.

    Time frame: 6 months

    Levels of insulin

  11. Index of the HOMA IR

    Time frame: 6 months

    Index of the HOMA IR

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 12, 2024
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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