Mild Cognitive ImpairmentNCT06254040
Effect of Consuming a Mixture of Extracts and DHA on the Mild Cognitive Impairment
A study testing mixture of extracts and DHA in people with Mild Cognitive Impairment, run by Biosearch S.A. at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 50 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- mixture of extracts and DHA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Complejo hospitalario Ruber Juan Bravo. Servicio de Neurología y Neurofisiología
Madrid, Madrid, 28006
About this study
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
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Placebo, mixture of extracts and DHA
- Keywords
- DHA, plant extracts, cognitive, brain
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary 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 DHADietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Volunteers will take 1 dissolving powder pack with maltodextrin daily for 6 months. Receives: Dietary Supplement: Placebo |
| Experimental Group | Experimental | Volunteers will take 1 dissolving powder pack with the mixture of extracts and DHA daily for 6 months. Receives: Dietary Supplement: mixture of extracts and DHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the Delayed Memory test.
Wechsler Memory Scale III questionnaire, delayed recall
Measured: 6 months
Secondary outcomes (11)
Score of the Mini Mental State Examination test.
Total score obtained in tests of: orientation, fixation, calculation and attention, memory, language and construction.
Measured: 6 months
Score of the Immediate Memory test.
Wechsler Memory Scale III questionnaire, immediate recall.
Measured: 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.
Measured: 6 months
Analysis of plasma levels of interleukins IL-6 to inflammatory parameters.
Levels of interleukins IL-6
Measured: 6 months
Analysis of plasma levels of interleukins IL-2 to inflammatory parameters.
Levels of interleukins IL-2
Measured: 6 months
Analysis of plasma levels of interleukins IL-10 to inflammatory parameters.
Levels of interleukins IL-10
Measured: 6 months
Analysis of plasma levels of PTX3 to inflammatory parameters.
Levels of PTX3
Measured: 6 months
Analysis of plasma levels of SAP to inflammatory parameters.
Levels of SAP.
Measured: 6 months
Analysis of plasma levels of glucose related to glucose metabolism.
Levels of glucose
Measured: 6 months
Analysis of plasma levels of insulin related to glucose metabolism.
Levels of insulin
Measured: 6 months
Index of the HOMA IR
Index of the HOMA IR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Jul 2022
- Primary completion1 Jul 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruth Blanco Rojo, PhD, Principal investigator, Biosearch S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254040
- Sponsor's protocol ID
- C029
- Status last verified
- Feb 2025
- First submitted
- 24 Aug 2022
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06254040
- Acronym / sponsor ID
- C029
- Conditions
- Mild Cognitive Impairment
- Keywords
- DHA, plant extracts, cognitive, brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Dietary Supplement: PlaceboVolunteers will take 1 dissolving powder pack with maltodextrin daily for 6 months. |
| Experimental Group | Experimental | Dietary Supplement: mixture of extracts and DHAVolunteers will take 1 dissolving powder pack with the mixture of extracts and DHA daily for 6 months. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboEach 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. | Dietary supplement | Control Group |
| mixture of extracts and DHAEach 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. | Dietary supplement | Experimental Group |
Primary outcome
Score of the Delayed Memory test.
Time frame: 6 months
Wechsler Memory Scale III questionnaire, delayed recall
11 secondary outcomes
Score of the Mini Mental State Examination test.
Time frame: 6 months
Score of the Immediate Memory test.
Time frame: 6 months
Total score of the ADAS-cog neurocognitive test.
Time frame: 6 months
Analysis of plasma levels of interleukins IL-6 to inflammatory parameters.
Time frame: 6 months
Analysis of plasma levels of interleukins IL-2 to inflammatory parameters.
Time frame: 6 months
Analysis of plasma levels of interleukins IL-10 to inflammatory parameters.
Time frame: 6 months
Analysis of plasma levels of PTX3 to inflammatory parameters.
Time frame: 6 months
Analysis of plasma levels of SAP to inflammatory parameters.
Time frame: 6 months
Analysis of plasma levels of glucose related to glucose metabolism.
Time frame: 6 months
Analysis of plasma levels of insulin related to glucose metabolism.
Time frame: 6 months
Index of the HOMA IR
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Blanco Rojo, PhD principal investigator
Biosearch S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mixture of extracts and DHA in people with Mild Cognitive Impairment, run by Biosearch S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of the Delayed Memory test. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.