Algal Lutein Against Decline of Intellectual Nimbleness

NCT07600567 | Not Yet Recruiting DMC

• 1 other identifier: ERA4HEALTHNUTRIBRAIN-154
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Lutein is a xanthophyll pigment found in photosynthesizing organisms. Its beneficial effects on health, including brain function and visual performance, have been recognized for many years. However, to date, only a limited number of well-designed human intervention studies have been published regarding the effects of incorporating lutein into the daily diet (as humans are unable to synthesize lutein endogenously). Unfortunately, within the Western dietary pattern, the average daily intake of lutein is approximately 1.7 mg, whereas achieving health benefits- such as reducing the risk of age-related macular degeneration and cataract, as well as neurodegenerative diseases- requires an intake of 6 to 14 mg per day. In light of the above, it is therefore justified to enrich the daily diet with products that are sources of lutein. Unfortunately, the consumption of dark green vegetables- the richest dietary source of lutein-remains insufficient. Lutein preparations currently available on the market are extracted from marigold or calendula flowers. However, lutein production from these raw materials requires greater water consumption and land use, which is not aligned with the principles of sustainable development. An alternative approach involves the production of lutein preparations from microalgae (from species approved as food by the European Food Safety Authority, EFSA), as the rate of lutein production from microalgae is three to six times higher than that from marigold flowers. Taking the above into account, the primary objective of this project is to evaluate the dose-response relationship in establishing the anti-aging mechanism of action of lutein derived from microalgae. As part of the project, a six-month randomized, placebo-controlled trial is planned. The study will include 300 polish women (aged 48-60 years), after natural menopause, with visceral obesity (waist circumference ≥ 88 cm). In order to enable the inclusion of such a large study population, the research team will conduct intensified recruitment efforts for several months prior to the initiation of the dietary intervention. Participants who meet the inclusion criteria will be randomly assigned to one of three groups: lutein supplementation at a dose of 6 mg (n = 100), lutein supplementation at a dose of 14 mg (n = 100), or placebo (n = 100). The volunteers will be instructed to take the prescribed preparation daily for 180 days. All preparations will be identical in appearance, taste, and smell. All volunteers expressing willingness to participate in the experiment will be asked to provide written informed consent prior to enrollment in the study. The study will be conducted in accordance with the previously calculated sample size (n = 300 postmenopausal women with visceral obesity). In order to obtain a homogeneous study population, appropriate inclusion and exclusion criteria will be applied. Conducting the research in such a large and homogeneous group will enable the generation of high-quality scientific evidence identifying the dose of microalgae-derived lutein that allows for the determination of its anti-aging mechanism of action. It will also be possible to elucidate the potential role of short-chain fatty acids (SCFAs) in feces in this process, which may represent a significant novelty in this field of research. The study will contribute to the development of new knowledge regarding the anti-aging properties of lutein derived from microalgae in populations vulnerable to cognitive impairment (postmenopausal women). However, microalgae-derived lutein may be used as a dietary supplement not only in the studied group but also in the general population. The specific objectives are as follows:

• To assess the effect of lutein derived from microalgae (at doses of 6 mg and 14 mg) on the concentration of brain-derived neurotrophic factor (BDNF), inflammatory markers, cardiometabolic parameters, fecal short-chain fatty acid (SCFA) concentrations, and cognitive function in postmenopausal women with visceral obesity.
• To evaluate adherence to lutein supplementation recommendations (by assessing macular pigment optical density).
• To determine whether supplementation with microalgal lutein increases fecal SCFA concentrations and whether SCFAs may act as mediators in improving inflammatory markers and cognitive function in postmenopausal women with visceral obesity.
• To determine whether supplementation with microalgal lutein (at doses of 6 mg and 14 mg) affects changes in selected gut bacterial populations and β-glucuronidase enzymatic activity in postmenopausal women with visceral obesity.
• To analyse the association between polymorphisms in genes related to lutein metabolism and transport in the body and the effectiveness of supplementation with this compound.
• To identify dietary behaviour patterns associated with high exposure to bisphenol A (BPA) and the presence of inflammation in postmenopausal women with visceral obesity.

Conditions

Menopausal Syndrome; Cognitive Decline; Obesity & Overweight; Menopause; Inflamation; Gut Dysbiosis; Bisphenol A; Cardio Vascular Disease

Keywords

menopausal syndrome; cognitive decline; obesity; menopause; inflammation; dysbiosis; bisphenol A; gut microbiota; BNDF; intellectual nimbleness; beta-glucuronidase; lutein; supplementation; micro-algae; gene polimorfism; eye vision; chlorella; sustainable development

Outcome Measures

Primary Outcomes (8)

• Serum IL-6 concentration [pg/ml] by ELISA

  Serum IL-6 will be analysed by the accredited laboratory by Enzyme-Linked Immunosorbent Assay (ELISA) quantitatively and will be expressed in pg/mL

  From enrollment to the end of treatment at 6 months

• Serum concentration of Brain-Derived Neurotrophic Factor (BDNF) [pg/mL]

  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.

  From enrollment to the end of treatment at 6 months

• Macular Pigment Optical Density (MPOD) measured in density units [d.u.]

  MPOD will be measured by the non-invasive optical measurements (lutein accumulates in the macula) based on heterochromatic flicker photometry technique.

  baseline and after 6 months of the intervention

• Neurocognitive Index score measured by CNS Vital Signs

  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.

  From enrollment to the end of treatment at 6 months

• Estrogen concentration [pg/ml] by ELISA.

  Estrogen concentrations \[pg/ml\] will be assesed from vascular blood sample at the Poznań University of Life Sciences by Enzyme-Linked Immunosorbent Assay (ELISA).

  From enrollment to the end of treatment at 6 months

• Gene polymorphisms CD36 (rs1761667), BCO1 (rs6564851, rs12934922, rs7501331) in blood

  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.

  From enrollment to the end of treatment at 6 months

• Serum Interleukin-1 beta (IL-1β) concentration [pg/ml] by ELISA

  IL-1β will be analysed by accredited laboratory by ELISA method. The result will be quantitative and expressed in pg/mL.

  From enrollment to the end of treatment at 6 months

• Tumor necrosis factor α (TNF-α) concentration [pg/ml] by ELISA

  Serum TNF-α will be analysed in accredited laboratory by the ELISA method. The results will be quantitative and expressed in pg/mL

  From enrollment to the end of treatment at 6 moths.

Secondary Outcomes (15)

• The abundance of selected gut bacteria determined by PCR

  From enrollment to the end of treatment at 6 months

• SCFA concentration [µmol/g] by GC-FID

  From enrollment to the end of treatment at 6 months

• β-glucuronidase activity [U/g stool] assessed by β-glucuronidase Activity Assay Kit (Fluorometric)

  From enrollment to the end of treatment at 6 months

• Fasting blood glucose concentration in mg/dl

  From enrollment to the end of treatment at 6 months

• Total cholesterol (TC) concentration in mg/dl

  From enrollment to the end of treatment at 6 months

Study Arms (3)

Lutein 6 mg

EXPERIMENTAL

Participants receive lutein supplementation at a dose of 6 mg daily for 180 days. The supplement is identical in appearance, taste, and smell to other study preparations.

Dietary Supplement: Lutein

Lutein 14 mg

EXPERIMENTAL

Participants receive lutein supplementation at a dose of 14 mg daily for 180 days. The supplement is identical in appearance, taste, and smell to other study preparations.

Dietary Supplement: Lutein

Placebo

PLACEBO COMPARATOR

Participants receive a placebo preparation daily for 180 days. The placebo is identical in appearance, taste, and smell to the lutein supplements.

Other: Placebo

Interventions

Lutein DIETARY_SUPPLEMENT

Participants receive oral lutein supplementation administered daily for 180 days. Two dosing regimens are used in the study: 6 mg/day and 14 mg/day. The supplement is identical in appearance, taste, and smell to the placebo preparation.

Lutein 14 mg; Lutein 6 mg

Placebo OTHER

Participants receive an oral placebo preparation administered daily for 180 days. The placebo is identical in appearance, taste, and smell to the lutein supplement.

Placebo

Eligibility Criteria

• Age: 48 Years - 60 Years
• Gender Eligibility Details: Eligible participants are biologically female individuals with natural postmenopausal status.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females
• Age 48-60 years
• Postmenopausal status (natural menopause, up to 5 years after menopause)
• waist circumference ≥ 88 cm

You may not qualify if:

• Diagnosis of dementia or cognitive impairment
• Use of hormone replacement therapy within the last 6 months
• Advanced age-related macular degeneration
• History of major untreated neurological or psychiatric disorders (including depression, Parkinson's disease, Alzheimer's disease, psychiatric disorders, stroke within the last 3 months)
• Presence of chronic diseases, including: diabetes mellitus (type 1 or 2), lipid disorders, cardiovascular diseases, thyroid diseases, anemia, liver diseases, gastrointestinal disorders, or cancer within the last 5 years
• Use of anti-inflammatory medications or medications targeting lipid or carbohydrate metabolism within the last 3 months
• Alcohol consumption \> 100 g per week
• Use of lutein-containing supplements

Sponsors & Collaborators

• Poznan University of Life Sciences: lead
• ERA4Health: Modulation of brain ageing through nutrition and healthy lifestyle (NutriBrain): collaborator
• Ecole Centrale Supélec: collaborator
• IBIMA Plataforma BIONAD: collaborator
• Flanders Research Institute for Agriculture, Fisheries and Food: collaborator
• ERA4Health: collaborator
• Narodowe Centrum Badań i Rozwoju: collaborator

Study Sites (1)

Faculty of Food Science and Nutrition, Poznan University of Life Sciences

Poznan, 60-637, Poland

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Obesity; Overweight; Inflammation; Dysbiosis

Interventions

Lutein

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: May 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-03

Locations

PL (1)