Algal Lutein Against Decline of Intellectual Nimbleness
NCT07600567, Not applicable, Not yet recruiting, Poznan University of Life Sciences
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Algal Lutein Against Decline of Intellectual Nimbleness | ClinicalTrials.gov |
| NCT number | NCT07600567 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 300 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Poznan University of Life Sciences | ClinicalTrials.gov |
| Conditions | Menopausal Syndrome, Cognitive Decline, Obesity & Overweight, Menopause, Inflamation, Gut Dysbiosis, Bisphenol A, Cardio Vascular Disease | ClinicalTrials.gov |
| Interventions | Lutein, Placebo | ClinicalTrials.gov |
| First posted | 2026-05-20 | ClinicalTrials.gov |
| Last updated | 2026-05-20 | ClinicalTrials.gov |
Registered outcomes 23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Serum IL-6 concentration [pg/ml] by ELISA | From enrollment to the end of treatment at 6 months | Serum IL-6 will be analysed by the accredited laboratory by Enzyme-Linked Immunosorbent Assay (ELISA) quantitatively and will be expressed in pg/mL | ClinicalTrials.gov |
| Primary | Serum concentration of Brain-Derived Neurotrophic Factor (BDNF) [pg/mL] | From enrollment to the end of treatment at 6 months | The BDNF concentration will be assessed from serum by ELISA method in the lab of Department of Human Nutrition and Dietetics, Poznan University of Life Sciences. | ClinicalTrials.gov |
| Primary | Macular Pigment Optical Density (MPOD) measured in density units [d.u.] | baseline and after 6 months of the intervention | MPOD will be measured by the non-invasive optical measurements (lutein accumulates in the macula) based on heterochromatic flicker photometry technique. | ClinicalTrials.gov |
| Primary | Neurocognitive Index score measured by CNS Vital Signs | From enrollment to the end of treatment at 6 months | To assess cognitive function, we will use the CNS Vital Signs neurocognitive test battery. The core 'BRIEF-CORE' battery consists of seven subtests: Verbal Memory (VBM), Visual Memory (VIM), Finger Tapping (FTT), Symbol Digit Coding (SDC), Stroop Test (ST), Continuous Attention Test (SAT), and Continuous Performance Test (CPT). These subtests provide quantitative scores across multiple cognitive domains, including complex memory, visual memory, verbal memory, psychomotor speed, motor speed, processing speed, reaction time, cognitive flexibility, executive function, complex attention, and simple attention. Cognitive function will be compared between baseline (pre-intervention) and post-intervention assessments to identify potential changes in performance. | ClinicalTrials.gov |
| Primary | Estrogen concentration [pg/ml] by ELISA. | From enrollment to the end of treatment at 6 months | Estrogen concentrations \[pg/ml\] will be assesed from vascular blood sample at the Poznań University of Life Sciences by Enzyme-Linked Immunosorbent Assay (ELISA). | ClinicalTrials.gov |
| Primary | Gene polymorphisms CD36 (rs1761667), BCO1 (rs6564851, rs12934922, rs7501331) in blood | From enrollment to the end of treatment at 6 months | The genomic DNA will be isolated using ready to use kits according to manufacturer protocols. The polymorphism of UGTs genes will be performed by real-time PCR using a TaqMan probe assay and a LightCycler 480II following the manufacturer's protocol. | ClinicalTrials.gov |
| Primary | Serum Interleukin-1 beta (IL-1β) concentration [pg/ml] by ELISA | From enrollment to the end of treatment at 6 months | IL-1β will be analysed by accredited laboratory by ELISA method. The result will be quantitative and expressed in pg/mL. | ClinicalTrials.gov |
| Primary | Tumor necrosis factor α (TNF-α) concentration [pg/ml] by ELISA | From enrollment to the end of treatment at 6 moths. | Serum TNF-α will be analysed in accredited laboratory by the ELISA method. The results will be quantitative and expressed in pg/mL | ClinicalTrials.gov |
| Secondary | The abundance of selected gut bacteria determined by PCR | From enrollment to the end of treatment at 6 months | Using the bacterial DNA obtained from stool samples, the abundance of selected gut bacteria (i.e. Bifidobacterium longum, Akkermansia muciniphila, Faecalibacterium prausnitzii) will be determined using PCR. | ClinicalTrials.gov |
| Secondary | SCFA concentration [µmol/g] by GC-FID | From enrollment to the end of treatment at 6 months | SCFA concentration \[µmol/g\] will be assessed using gas chromatography with flame ionisation detection (GC-FID). The research will be carried out at the Department of Bromatology, Poznań University of Medical Sciences. | ClinicalTrials.gov |
| Secondary | β-glucuronidase activity [U/g stool] assessed by β-glucuronidase Activity Assay Kit (Fluorometric) | From enrollment to the end of treatment at 6 months | A faecal sample will be dissolved in a buffer solution and homogenised, and β-glucuronidase activity will be determined based on the hydrolysis of a specific substrate into a fluorescent product. The β-glucuronidase assay will be performed both before and after the completion of the 6-month experiment. | ClinicalTrials.gov |
| Secondary | Fasting blood glucose concentration in mg/dl | From enrollment to the end of treatment at 6 months | Fasting blood glucose concentration measured in venous blood samples using standard laboratory methods. | ClinicalTrials.gov |
| Secondary | Total cholesterol (TC) concentration in mg/dl | From enrollment to the end of treatment at 6 months | Serum TC concentration measured using standard laboratory methods. | ClinicalTrials.gov |
| Secondary | Low-density lipoprotein (LDL) cholesterol concentration in mg/dL | From enrollment to the end of treatment at 6 months | Serum LDL concentration measured using standard laboratory methods. | ClinicalTrials.gov |
| Secondary | High-density lipoprotein (HDL) cholesterol concentration in mg/dL | From enrollment to the end of treatment at 6 months | Serum HDL concentration measured using standard laboratory methods. | ClinicalTrials.gov |
| Secondary | Triglyceride (TG) concentration in mg/dL | From enrollment to the end of treatment at 6 months | Serum TG concentration measured using standard laboratory methods. | ClinicalTrials.gov |
| Secondary | Body weight [kg] | From enrollment to the end of treatment at 6 months | Body weight is measured in a standing position, without shoes, in light clothing, to an accuracy of 0.1 kg. | ClinicalTrials.gov |
| Secondary | Body height [cm] | From enrollment to the end of treatment at 6 months | Body height will be measured using a medical anthropometer to an accuracy of 0.5 cm. The measurement will be taken barefoot, in a standing position - without excessive tension in the body, shoulders relaxed, upper and lower limbs freely extended, feet together with heels touching and weight evenly distributed, head positioned in the eye-ear plane (Frankfurt plane; the upper edges of the external auditory meatus and the lower edge of the orbit at the same level). | ClinicalTrials.gov |
| Secondary | Waist to hip ratio [-] by non-elastic measure tape | From enrollment to the end of treatment at 6 months | Hip and waist circumferences will be taken using a non-stretch tape measure \[cm\]. Waist circumference measurement - the tape measure should be placed horizontally or at a slight angle halfway between the lower edge of the ribs and the upper edge of the iliac crest. The measurement should be taken whilst holding one's breath. Ratio between the waist and hip circumference will be taken. | ClinicalTrials.gov |
| Secondary | Body composition (visceral fat, lean muscle mass and bone density) [kg] measured by DXA | From enrollment to the end of treatment at 6 months | Body composition will be measured using dual-energy X-ray absorptiometry (DXA), a method that utilises the attenuation of ionising radiation as it passes through tissues of varying density. This method is safe and non-invasive. It measures body fat mass, including visceral fat, lean body mass and bone density. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Continuous Performance Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.