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

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254040
• Other study ID #: C029
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Biosearch S.A.
• Contact: Ruth Blanco Rojo, PhD
• Phone: +34913802973
• Email: ruth.blanco[@]kerry.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Complejo hospitalario Ruber Juan Bravo. Servicio de Neurología y Neurofisiología	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of the Delayed Memory test.	Wechsler Memory Scale III questionnaire, delayed recall	6 months
Secondary	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
Secondary	Score of the Immediate Memory test.	Wechsler Memory Scale III questionnaire, immediate recall.	6 months
Secondary	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
Secondary	Analysis of plasma levels of interleukins IL-6 to inflammatory parameters.	Levels of interleukins IL-6	6 months
Secondary	Analysis of plasma levels of interleukins IL-2 to inflammatory parameters.	Levels of interleukins IL-2	6 months
Secondary	Analysis of plasma levels of interleukins IL-10 to inflammatory parameters.	Levels of interleukins IL-10	6 months
Secondary	Analysis of plasma levels of PTX3 to inflammatory parameters.	Levels of PTX3	6 months
Secondary	Analysis of plasma levels of SAP to inflammatory parameters.	Levels of SAP.	6 months
Secondary	Analysis of plasma levels of glucose related to glucose metabolism.	Levels of glucose	6 months
Secondary	Analysis of plasma levels of insulin related to glucose metabolism.	Levels of insulin	6 months
Secondary	Index of the HOMA IR	Index of the HOMA IR	6 months