Cognitive FunctionREVIVENCT07879703
Nutraceutical Clinical Trial to Evaluate the Effects of Different Blends in Cognitive Functions of Healthy Volunteers
A study testing Polyphenol-rich fruit and vegetable nutraceutical in people with Cognitive Function and Healthy Volunteers, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
The present research is a randomized, sex-stratified, cross-over and placebo-controlled clinical trial, designed to evaluate the effect of daily intake of a dietary supplement (Premium®) on cognitive function and psychological well-being compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Healthy Volunteers
- What is being tested?
- Polyphenol-rich fruit and vegetable nutraceutical
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 28 Sep 2018to 20 Jun 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Submit at the time of signing the informed consent at or above age or 18 years.
- In both sexes, Caucasians and selected from the population of students from the UCAM
- Subjects which have a BMI between 18.5 and 35 kg / m2. (With the stratification of BMI based on the classification of overweight and obesity according to WHO)
- Healthy subjects without any chronic disease.
- Subjects whose intake of fruits and / or vegetables less than three pieces a day.
- Volunteers able to understand the clinical study, willing to give written informed consent and to comply with the procedures and requirements of the study.
Who cannot join
- Subjects with fluctuations in physical activity during the course of the study.
- Pregnant or nursing woman.
- Smokers subjects. The criterion used to exclude smokers is that they can mask the results, since although they are stratified, We believe that the influence on liver and microsomal function is reduced
- Subjects consuming medication, food supplements or nutraceuticals with antioxidant properties.
- Subjects with chronic medication, except ACO.
- Subjects under treatment with benzodiazepines, or non-benzodiazepine derivatives.
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- Any clinically significant pathology, advanced or unstable that may interfere with assessments of the primary or secondary variables, distort the clinician or mental examination or pose a particular risk to the patient.
- Subjects who consumed multivitamins.
- Subjects treated with drugs for their narrow therapeutic require monitoring plasma levels (digoxin, acenocoumarol, warfarin, etc ...).
- Subjects in treatment affecting body weight or appetite.
- History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- Subjects who are performing or intending to perform any type of food, low-calorie or no regime during the study.
- Subjects who have donated a minimum of 0.5L of blood in the last month
- Vegetarian, vegan or with any type of restriction macronutritiv subjects.
- Excluded those subjects with alcohol abuse or excessive consumption of alcohol (> 3 glasses of wine or beer / day)
- Patients undergoing major surgery in the last 3 months.
- Subjects with problems in conciliation and / or sleep maintenance.
- Subjects with a history of drug, alcohol or other substance abuse or other factors that limit their ability to cooperate during the study.
- Subjects whose condition does not make them eligible for the study, at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The present research is a randomized, sex-stratified, cross-over and placebo-controlled clinical trial, designed to evaluate the effect of daily intake of a dietary supplement (Premium®) on cognitive function and psychological well-being compared to placebo.
Read the detailed description
It is indicated in numerous studies, that the content of fruits and vegetables, and therefore of the antioxidant compounds present, have a great capacity to neutralize free radicals, avoiding and preventing the deterioration of aging and degenerative diseases. The main effects tested are reducing the adverse effects caused by air pollution and free radicals that this causes in the organism that decreases oxidative damage, or exerting the ability of anti-inflammatory and neuroprotective effects. For example, in patients with kidney disease undergoing hemodialysis, a red grape supplement rich in polyphenols has demonstrated the ability to reduce the damage caused by oxidative stress.
The amount of bioactive compounds with antioxidants that are beneficial to the body varies according to the fruits and vegetables in question. For example, the pomegranate has a better antioxidant capacity than an apple and has values very similar to the different types of berries. This capacity depends on the amount of consumption of each of them, as well as the duration of consumption.
The mechanisms of action of this antioxidant activity in the body of the bioactive compound compounds that fruits and vegetables contain, have been determined in different previous research studies. In all cases, the antioxidant capacity shown by different fruits and vegetables depended on the concentration of polyphenols and enzymes of the kinase chain. For example, in the case of the prevention and control of type II diabetes, the main mechanism is diabetes by inhibiting the enzymes involved in the digestion of carbohydrates such as α-amylase or α-glucosidase or reducing agents. inflammation in diabetes with compromise in the metabolic syndrome and obesity with the corresponding oxidative stress.
In other cases, the effect of the combination of any of them has also been proven. Although the effect of these is positive, for example in the case of pomegranate and lemon, it shows that there is a positive synergy in both, the effect of the combination being better than separately The intervention of fruits and vegetables in cognition, for example, the improvement is associated with the decrease caused by age, shows a greater relationship in the case of flavonoids and especially anthocyanins and flavones.
The contracted would be in charge of the implementation and development of the following parts of the study, as well as the management and processing of obtained data, writing of scientific articles and help with the group's research tasks.
Study design. The contracted would carry out the recruitment phase. The randomized study, stratified by sex, crossed and controlled with placebo, designed to evaluate the effect of the daily intake of a dietary supplement on cognitive function and psychological well-being in comparison with placebo.
Duration of the study
- Recruitment phase: the recruitment of volunteers for the study will be carried out during the 2 months prior to the start of the intervention period. Volunteers will be recruited through email, information sessions, announcements etc.
- Selection phase: the Informed Consent sheet will be given to the volunteers so that, once they understand everything about the study, they agree to participate in the study.
The subjects will be evaluated and previously interviewed at the beginning of the study to know if they meet the inclusion / exclusion criteria.
- Product consumption (intervention period): Volunteers will be randomly divided into two similar groups (N1 = 50 and N2 = 50). The intervention period is divided into two phases of 16 weeks each, including a washout period of 4 weeks between the two phases.
Control appointments (the contracted will be responsible for monitoring and citing them): each volunteer will be controlled during the intervention period through 4 visits throughout the study. The visits will be made at the beginning and at the end of both phases of intervention. A period of time of ± 4 days will be established to make the visits. During each visit, determinations will be made regarding the different parameters studied.
- Conditions
- Cognitive Function, Healthy Volunteers
- Being tested
- Polyphenol-rich fruit and vegetable nutraceutical, Placebo
- Keywords
- Nutrition, fruits, vegetables, Cognitive Function, Polyphenols, Nutraceutical, BDNF, CREB, Stroop Test, Trail Making Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenol-rich fruit and vegetable nutraceuticalDietary supplement
Participants receive six capsules daily of a polyphenol-rich fruit, vegetable, and berry nutraceutical during the active 16-week intervention period.
PlaceboDietary supplement
Participants receive matching placebo capsules daily during the placebo 16-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Juice plus | Active comparator | Not described Receives: Dietary Supplement: Polyphenol-rich fruit and vegetable nutraceutical |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inhibitory control and selective attention measured by the Stroop Test
Inhibitory control and selective attention will be assessed using the Stroop Test. The primary endpoint is the change in Stroop Test performance from baseline to the end of each 16-week intervention period; higher performance indicates better cognitive function according to the scoring method used.
Measured: Baseline to the end of each 16-week intervention period
Change in processing speed and cognitive flexibility measured by the Trail Making Test
Processing speed and cognitive flexibility will be assessed using the Trail Making Test. The outcome is the change in completion time from baseline to the end of each 16-week intervention period; shorter completion time indicates better performance.
Measured: Baseline to the end of each 16-week intervention period
Change in verbal memory and logical reasoning measured by the Reynolds Intellectual Screening Test
Verbal memory and logical reasoning will be assessed using the Reynolds Intellectual Screening Test. The outcome is the change in test score from baseline to the end of each 16-week intervention period; higher scores indicate better cognitive performance.
Measured: Baseline to the end of each 16-week intervention period
Secondary outcomes (2)
Change in blood brain-derived neurotrophic factor concentration
Blood samples will be analyzed to assess brain-derived neurotrophic factor concentration as a biomarker related to synaptic plasticity and neuroprotection.
Measured: Baseline to the end of each 16-week intervention period
Change in blood cAMP response element-binding protein concentration
Blood samples will be analyzed to assess cAMP response element-binding protein concentration as a biomarker related to synaptic plasticity and neuroprotection.
Measured: Baseline to the end of each 16-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start28 Sep 2018
- Primary completion20 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive FunctionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, sex-stratified, double-blind, placebo-controlled crossover trial evaluating the effect of daily intake of a polyphenol-rich fruit and vegetable nutraceutical on cognitive function and neuroprotective biomarkers in healthy adults.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- The Juice Plus+ Company
- Responsible party
- Principal investigator, Javier Marhuenda, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879703
- Sponsor's protocol ID
- CFE/JU/44-17
- Acronym
- REVIVE
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carrillo JA, Arcusa R, Xandri-Martinez R, Cerda B, Zafrilla P, Marhuenda J. Impact of Polyphenol-Rich Nutraceuticals on Cognitive Function and Neuroprotective Biomarkers: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients. 2025 Feb 7;17(4):601. doi: 10.3390/nu17040601.
PubMed 40004930
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutraceutical Clinical Trial to Evaluate the Effects of Different Blends in Cognitive Functions of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07879703
- Acronym / sponsor ID
- REVIVE / CFE/JU/44-17
- Conditions
- Cognitive Function, Healthy Volunteers
- Keywords
- Nutrition, fruits, vegetables, Cognitive Function, Polyphenols, Nutraceutical, BDNF, CREB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Collaborators
- The Juice Plus+ Company
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 19 Oct 2026 (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 present research is a randomized, sex-stratified, cross-over and placebo-controlled clinical trial, designed to evaluate the effect of daily intake of a dietary supplement (Premium®) on cognitive function and psychological well-being compared to placebo.
Detailed description
It is indicated in numerous studies, that the content of fruits and vegetables, and therefore of the antioxidant compounds present, have a great capacity to neutralize free radicals, avoiding and preventing the deterioration of aging and degenerative diseases. The main effects tested are reducing the adverse effects caused by air pollution and free radicals that this causes in the organism that decreases oxidative damage, or exerting the ability of anti-inflammatory and neuroprotective effects. For example, in patients with kidney disease undergoing hemodialysis, a red grape supplement rich in polyphenols has demonstrated the ability to reduce the damage caused by oxidative stress.
The amount of bioactive compounds with antioxidants that are beneficial to the body varies according to the fruits and vegetables in question. For example, the pomegranate has a better antioxidant capacity than an apple and has values very similar to the different types of berries. This capacity depends on the amount of consumption of each of them, as well as the duration of consumption.
The mechanisms of action of this antioxidant activity in the body of the bioactive compound compounds that fruits and vegetables contain, have been determined in different previous research studies. In all cases, the antioxidant capacity shown by different fruits and vegetables depended on the concentration of polyphenols and enzymes of the kinase chain. For example, in the case of the prevention and control of type II diabetes, the main mechanism is diabetes by inhibiting the enzymes involved in the digestion of carbohydrates such as α-amylase or α-glucosidase or reducing agents. inflammation in diabetes with compromise in the metabolic syndrome and obesity with the corresponding oxidative stress.
In other cases, the effect of the combination of any of them has also been proven. Although the effect of these is positive, for example in the case of pomegranate and lemon, it shows that there is a positive synergy in both, the effect of the combination being better than separately The intervention of fruits and vegetables in cognition, for example, the improvement is associated with the decrease caused by age, shows a greater relationship in the case of flavonoids and especially anthocyanins and flavones.
The contracted would be in charge of the implementation and development of the following parts of the study, as well as the management and processing of obtained data, writing of scientific articles and help with the group's research tasks.
Study design. The contracted would carry out the recruitment phase. The randomized study, stratified by sex, crossed and controlled with placebo, designed to evaluate the effect of the daily intake of a dietary supplement on cognitive function and psychological well-being in comparison with placebo.
Duration of the study
- Recruitment phase: the recruitment of volunteers for the study will be carried out during the 2 months prior to the start of the intervention period. Volunteers will be recruited through email, information sessions, announcements etc.
- Selection phase: the Informed Consent sheet will be given to the volunteers so that, once they understand everything about the study, they agree to participate in the study.
The subjects will be evaluated and previously interviewed at the beginning of the study to know if they meet the inclusion / exclusion criteria.
- Product consumption (intervention period): Volunteers will be randomly divided into two similar groups (N1 = 50 and N2 = 50). The intervention period is divided into two phases of 16 weeks each, including a washout period of 4 weeks between the two phases.
Control appointments (the contracted will be responsible for monitoring and citing them): each volunteer will be controlled during the intervention period through 4 visits throughout the study. The visits will be made at the beginning and at the end of both phases of intervention. A period of time of ± 4 days will be established to make the visits. During each visit, determinations will be made regarding the different parameters studied.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, sex-stratified, double-blind, placebo-controlled crossover trial evaluating the effect of daily intake of a polyphenol-rich fruit and vegetable nutraceutical on cognitive function and neuroprotective biomarkers in healthy adults.
| Arm | Type | Receives |
|---|---|---|
| Juice plus | Active comparator | Dietary Supplement: Polyphenol-rich fruit and vegetable nutraceutical |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Submit at the time of signing the informed consent at or above age or 18 years.
- In both sexes, Caucasians and selected from the population of students from the UCAM
- Subjects which have a BMI between 18.5 and 35 kg / m2. (With the stratification of BMI based on the classification of overweight and obesity according to WHO)
- Healthy subjects without any chronic disease.
- Subjects whose intake of fruits and / or vegetables less than three pieces a day.
Key exclusion criteria (19 listed)
- Subjects with fluctuations in physical activity during the course of the study.
- Pregnant or nursing woman.
- Smokers subjects. The criterion used to exclude smokers is that they can mask the results, since although they are stratified, We believe that the influence on liver and microsomal function is reduced
- Subjects consuming medication, food supplements or nutraceuticals with antioxidant properties.
- Subjects with chronic medication, except ACO.
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 |
|---|---|---|
| Polyphenol-rich fruit and vegetable nutraceuticalParticipants receive six capsules daily of a polyphenol-rich fruit, vegetable, and berry nutraceutical during the active 16-week intervention period. | Dietary supplement | Juice plus |
| PlaceboParticipants receive matching placebo capsules daily during the placebo 16-week intervention period. | Dietary supplement | Placebo |
Primary outcome
Change in inhibitory control and selective attention measured by the Stroop Test
Time frame: Baseline to the end of each 16-week intervention period
Inhibitory control and selective attention will be assessed using the Stroop Test. The primary endpoint is the change in Stroop Test performance from baseline to the end of each 16-week intervention period; higher performance indicates better cognitive function according to the scoring method used.
Change in processing speed and cognitive flexibility measured by the Trail Making Test
Time frame: Baseline to the end of each 16-week intervention period
Processing speed and cognitive flexibility will be assessed using the Trail Making Test. The outcome is the change in completion time from baseline to the end of each 16-week intervention period; shorter completion time indicates better performance.
Change in verbal memory and logical reasoning measured by the Reynolds Intellectual Screening Test
Time frame: Baseline to the end of each 16-week intervention period
Verbal memory and logical reasoning will be assessed using the Reynolds Intellectual Screening Test. The outcome is the change in test score from baseline to the end of each 16-week intervention period; higher scores indicate better cognitive performance.
2 secondary outcomes
Change in blood brain-derived neurotrophic factor concentration
Time frame: Baseline to the end of each 16-week intervention period
Change in blood cAMP response element-binding protein concentration
Time frame: Baseline to the end of each 16-week intervention period
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 19 Oct 2026.
- Results publication: PubMed 40004930Carrillo JA, Arcusa R, Xandri-Martinez R, Cerda B, Zafrilla P, Marhuenda J. Impact of Polyphenol-Rich Nutraceuticals on Cognitive Function and Neuroprotective Biomarkers: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients. 2025 Feb 7;17(4):601. doi: 10.3390/nu17040601.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenol-rich fruit and vegetable nutraceutical in people with Cognitive Function and Healthy Volunteers, run by Universidad Católica San Antonio de Murcia 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 6 inclusion and 19 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 19 Oct 2026. 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?
Change in inhibitory control and selective attention measured by the Stroop Test (time frame: Baseline to the end of each 16-week intervention period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07879703, which also lists 1 linked publication.
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 19 Oct 2026.