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

Biosearch Life

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Dietary Supplement: mixture of extracts and DHA; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06254040

C029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Experimental Group

Experimental group

Description:

Volunteers will take 1 dissolving powder pack with the mixture of extracts and DHA daily for 6 months.

Treatment:

Dietary Supplement: mixture of extracts and DHA