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Algal Lutein Against Decline of Intellectual Nimbleness (ALADIN)

2026年5月13日 更新者：Poznan University of Life Sciences

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.

調査の概要

状態

状態

現在の募集状況やアクセス拡大状況を示します。
まだ募集していません

条件

条件

研究されている疾患、障害、症候群、病気、またはけが。 ClinicalTrials.gov では、条件には、寿命、生活の質、健康上のリスクなど、他の健康関連の問題も含まれる場合があります。

介入・治療

介入・治療

臨床研究の焦点となるプロセスまたはアクション。介入には、医薬品、医療機器、処置、ワクチン、および治験中またはすでに利用可能なその他の製品が含まれます。介入には、教育や食事や運動の変更などの非侵襲的アプローチも含まれます。

詳細な説明

The primary endpoint will include the assessment of:

  • cognitive function;
  • macular pigment optical density;
  • inflammatory markers (IL-6, IL-10, IL-1β, TNF-α, β-amyloid);
  • blood estrogen concentration;
  • levels of brain-derived neurotrophic factor (BDNF);
  • the abundance of selected gut bacterial populations and β-glucuronidase activity;
  • polymorphisms in genes associated with lutein metabolism and transport.

The secondary endpoint will include the assessment of:

  • cardiometabolic parameters (lipid profile: total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides; fasting glucose and insulin);
  • concentrations of gut microbiota metabolites in feces (short-chain fatty acids; SCFAs);
  • anthropometric parameters and bone mineral density;
  • arterial blood pressure.

At the screening stage, a brief Montreal Cognitive Assessment (MoCA) will be administered to ensure the inclusion of participants who do not exhibit symptoms of dementia.

Follow-up visits will be conducted at four-week intervals. Anthropometric parameters (body weight, waist circumference, and body composition) will be measured at each follow-up visit. Cognitive function will be assessed using selected standardized tests from the CNS Vital Signs battery before the initiation and after completion of the intervention.

Biochemical blood parameters, including inflammatory markers (IL-6, TNF-α, IL-1β, IL-10), insulin, brain-derived neurotrophic factor (BDNF), β-amyloid, lipid profile, glucose, and estrogen concentrations, will be measured before and after the intervention.

An additional 5 mL blood sample will be collected for the assessment of gene polymorphisms in CD36 (rs1761667) and BCO1 (rs6564851, rs12934922, rs7501331). Fecal short-chain fatty acids (SCFAs) and β-glucuronidase activity will also be assessed before and after the intervention.

Bacterial DNA will be isolated from stool samples using the QIAamp DNA Mini Kit according to the manufacturer's instructions, and the abundance of selected gut bacteria will subsequently be determined. The remaining biological material will be stored at -20°C (biobank) pending further analyses.

Macular pigment optical density (MPOD) will be assessed before and after the intervention using the computerized Macular Pigment Screener MPS II. In addition, prior to the intervention, participants will be required to complete a 24-hour urine collection for the determination of bisphenol A (BPA) concentration. Adherence to supplementation recommendations and tolerance of the lutein supplement will be evaluated at each follow-up visit using a questionnaire.

The tested supplement will consist of capsules containing "Green Chlorella Prime" powder, manufactured by the French company Biorea. The company is authorized to produce dietary supplements in accordance with ISO 22000/FSSC and GMP+ standards. The FSSC 22000 certificate is an international food safety standard that protects both companies and consumer health. The supplement used in the study will contain lutein derived from Chlorella sorokiniana and will be produced using optimized technological processes to obtain a microalgal supplement with a high lutein content.

The study will be conducted in a double-blind manner; neither the participants nor the research staff conducting the assessments will be aware of group allocation. All participants will be instructed to take the prescribed dose daily for 180 days. Compliance with supplementation will be verified by measuring macular pigment optical density. Participants will be asked to record supplement intake and return empty packaging at each follow-up visit. Supplement tolerance will be assessed during each visit using a questionnaire.

Assessment of Cognitive Function Neuropsychological evaluation will be conducted before and after the intervention using the CNS Vital Signs clinical test battery, comprising seven tests assessing verbal memory, visual memory, psychomotor speed, cognitive flexibility, complex attention, processing speed, reaction time, executive functioning, and reasoning.

Assessment of Macular Pigment Optical Density Macular pigment optical density will be assessed before and after the intervention using the computerized Macular Pigment Screener MPS II.

Dietary Assessment Dietary intake will be evaluated before and after the intervention using the KomPAN questionnaire, supplemented by four 24-hour dietary recalls.

Nutritional Status Assessment Nutritional status assessment will include baseline determination and monitoring of selected anthropometric parameters (body weight, body composition including visceral adipose tissue, waist and hip circumference, bone density) as well as selected biochemical blood parameters.

Height will be measured using a medical stadiometer to the nearest 0.5 cm under standardized conditions. Body weight will be measured to the nearest 0.1 kg with participants standing barefoot in light clothing.

Body composition will be assessed using dual-energy X-ray absorptiometry (DXA), a safe and non-invasive method based on the differential attenuation of ionizing radiation by tissues of varying density. Fat mass (including visceral fat), lean mass, and bone mineral density will be measured.

Waist and hip circumferences will be measured using a non-elastic measuring tape according to standardized anatomical landmarks.

All anthropometric measurements and assessments of nutritional and dietary status will be conducted at the Department of Human Nutrition and Dietetics, Faculty of Food Science and Nutrition, at the Nutrition Research Center.

Biochemical Blood Parameters Among enrolled participants, the following biochemical blood parameters will be determined: fasting glucose and insulin; lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides); IL-6, IL-10, IL-1β, TNF-α, β-amyloid; BDNF; and estrogen levels.

Blood samples will be collected by a qualified nurse at the Nutrition Research Center of the Department of Human Nutrition and Dietetics, Poznań University of Life Sciences. Blood will be drawn twice (before and after the intervention) from the antecubital vein in a fasting state into clot-activator tubes (18 mL + 5 mL for genotyping). Serum will be obtained by centrifugation. Insulin, inflammatory markers, β-amyloid, BDNF, and estrogens will be measured using ELISA assays, whereas glucose and lipid profile parameters will be analyzed using a Konelab biochemical analyzer. Biological material for further analyses will be stored at -80°C.

Genomic DNA Isolation Genomic DNA will be isolated from peripheral blood using commercial TaqMan assays. Genotyping will be performed using Real-Time PCR, combining PCR amplification with fluorescent probe detection to identify single nucleotide polymorphisms. An additional 5 mL of whole blood collected into EDTA tubes will be required for DNA isolation.

Determination of Bisphenol A (BPA) in Urine Prior to the intervention, each participant will complete a 24-hour urine collection. BPA concentration will be determined using ultra-high-performance liquid chromatography with diode-array detection (UPLC-DAD).

Determination of Short-Chain Fatty Acids in Feces Participants will provide stool samples at baseline and at the final visit. Quantitative determination of SCFAs will be performed using gas chromatography with flame ionization detection (GC-FID) at the Department of Bromatology, Poznań University of Medical Sciences.

Assessment of β-Glucuronidase Activity A portion of the stool sample will be homogenized in buffer solution, and β-glucuronidase activity will be determined based on the hydrolysis of a specific substrate to a fluorescent product, both before and after the six-month intervention.

Biobank Preparation and Microbiota Analysis Fresh bacterial DNA will be isolated from stool samples using the QIAamp DNA Mini Kit according to the manufacturer's protocol and stored at -20°C for future in-depth microbiota analyses. The abundance of selected gut bacteria (e.g., Bifidobacterium longum, Akkermansia muciniphila, Faecalibacterium prausnitzii) will be determined by PCR.

Participants will be recruited through public advertisements inviting volunteers to participate in scientific research and will be enrolled after receiving detailed information regarding the study objectives, protocol, measurements performed, and study duration.

研究の種類

研究の種類

臨床研究の性質について説明します。研究の種類には、介入研究 (臨床試験とも呼ばれます)、観察研究 (患者登録を含む)、および拡張アクセスが含まれます。
介入

入学 (推定)

入学

臨床試験の参加者数。 「予想される」登録は、研究者が研究に必要とする参加者の目標数です。
300

段階

段階

米国食品医薬品局 (FDA) によって開発された定義に基づく、医薬品または生物学的製品を研究する臨床試験の段階。フェーズは、研究の目的、参加者の数、およびその他の特性に基づいています。初期フェーズ 1 (以前はフェーズ 0 としてリストされていた)、フェーズ 1、フェーズ 2、フェーズ 3、およびフェーズ 4 の 5 つのフェーズがあります。該当なしは、デバイスまたは行動介入の治験を含む、FDA が定義したフェーズのない治験を説明するために使用されます。
  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • ポーランド
      • Poznan、ポーランド、60-637
        • Faculty of Food Science and Nutrition, Poznan University of Life Sciences
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Joanna Bajerska, Professor
        • 副調査官：
          • Karolina Lagowska, Doctor with habilitation
        • 副調査官：
          • Aleksandra Bykowska-Derda, Doctor of Philosophy
        • 副調査官：
          • Joanna Pieczynska-Zajac, Doctor of Philosophy
        • 副調査官：
          • Wiktoria Stanislawska, Master of Science
        • 副調査官：
          • Dagmara Ptaszynska, Master of Science
        • 副調査官：
          • Magdalena Debinska-Kubiak, Master of Science

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

適格基準

臨床研究への参加を希望する人々が満たさなければならない重要な要件、または彼らが持つべき特徴。適格基準は、包含基準 (人が研究に参加するために必要な基準) と除外基準 (人が研究に参加するのを妨げる基準) の両方で構成されます。適格基準のタイプには、研究が健康なボランティアを受け入れるかどうか、年齢または年齢グループの要件があるかどうか、または性別によって制限されるかどうかが含まれます。

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム

参加者グループ / アーム

臨床試験のプロトコルに従って、特定の介入/治療を受ける、または介入を受けない、臨床試験の参加者のグループまたはサブグループ。
介入・治療

介入・治療

臨床研究の焦点となるプロセスまたはアクション。介入には、医薬品、医療機器、処置、ワクチン、および治験中またはすでに利用可能なその他の製品が含まれます。介入には、教育や食事や運動の変更などの非侵襲的アプローチも含まれます。
実験的：Lutein 6 mg
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.
ダイエットサプリメント：Lutein
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.
実験的：Lutein 14 mg
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.
ダイエットサプリメント：Lutein
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.
プラセボコンパレーター：Placebo
Participants receive a placebo preparation daily for 180 days. The placebo is identical in appearance, taste, and smell to the lutein supplements.
他の：Placebo
Participants receive an oral placebo preparation administered daily for 180 days. The placebo is identical in appearance, taste, and smell to the lutein supplement.

この研究は何を測定していますか？

主要な結果の測定

主要な結果の測定

臨床研究のプロトコルにおいて、介入/治療の効果を評価するために最も重要な、計画された結果の尺度。ほとんどの臨床研究には 1 つの主要な結果の測定値がありますが、複数の測定値を持つものもあります。
結果測定
メジャーの説明
時間枠
Serum IL-6 concentration [pg/ml] by ELISA
時間枠：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
From enrollment to the end of treatment at 6 months
Serum concentration of Brain-Derived Neurotrophic Factor (BDNF) [pg/mL]
時間枠：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.
From enrollment to the end of treatment at 6 months
Macular Pigment Optical Density (MPOD) measured in density units [d.u.]
時間枠：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.
baseline and after 6 months of the intervention
Neurocognitive Index score measured by CNS Vital Signs
時間枠：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.
From enrollment to the end of treatment at 6 months
Estrogen concentration [pg/ml] by ELISA.
時間枠：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).
From enrollment to the end of treatment at 6 months
Gene polymorphisms CD36 (rs1761667), BCO1 (rs6564851, rs12934922, rs7501331) in blood
時間枠：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.
From enrollment to the end of treatment at 6 months
Serum Interleukin-1 beta (IL-1β) concentration [pg/ml] by ELISA
時間枠：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.
From enrollment to the end of treatment at 6 months
Tumor necrosis factor α (TNF-α) concentration [pg/ml] by ELISA
時間枠：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
From enrollment to the end of treatment at 6 moths.

二次結果の測定

二次結果の測定

臨床研究のプロトコルにおいて、介入の効果を評価するための主要な結果測定ほど重要ではないが、依然として重要な計画された結果測定。ほとんどの臨床研究には、複数の副次的アウトカム指標があります。
結果測定
メジャーの説明
時間枠
The abundance of selected gut bacteria determined by PCR
時間枠：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.
From enrollment to the end of treatment at 6 months
SCFA concentration [µmol/g] by GC-FID
時間枠：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.
From enrollment to the end of treatment at 6 months
β-glucuronidase activity [U/g stool] assessed by β-glucuronidase Activity Assay Kit (Fluorometric)
時間枠：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.
From enrollment to the end of treatment at 6 months
Fasting blood glucose concentration in mg/dl
時間枠：From enrollment to the end of treatment at 6 months
Fasting blood glucose concentration measured in venous blood samples using standard laboratory methods.
From enrollment to the end of treatment at 6 months
Total cholesterol (TC) concentration in mg/dl
時間枠：From enrollment to the end of treatment at 6 months
Serum TC concentration measured using standard laboratory methods.
From enrollment to the end of treatment at 6 months
Low-density lipoprotein (LDL) cholesterol concentration in mg/dL
時間枠：From enrollment to the end of treatment at 6 months
Serum LDL concentration measured using standard laboratory methods.
From enrollment to the end of treatment at 6 months
High-density lipoprotein (HDL) cholesterol concentration in mg/dL
時間枠：From enrollment to the end of treatment at 6 months
Serum HDL concentration measured using standard laboratory methods.
From enrollment to the end of treatment at 6 months
Triglyceride (TG) concentration in mg/dL
時間枠：From enrollment to the end of treatment at 6 months
Serum TG concentration measured using standard laboratory methods.
From enrollment to the end of treatment at 6 months
Body weight [kg]
時間枠：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.
From enrollment to the end of treatment at 6 months
Body height [cm]
時間枠：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).
From enrollment to the end of treatment at 6 months
Waist to hip ratio [-] by non-elastic measure tape
時間枠：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.
From enrollment to the end of treatment at 6 months
Body composition (visceral fat, lean muscle mass and bone density) [kg] measured by DXA
時間枠：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.
From enrollment to the end of treatment at 6 months
Bisphenol A (BPA) concentration [μg/L] by high-performance liquid chromatography (HPLC)-Diode Array Detector (DAD)
時間枠：baseline only
Detection by DAD will be carried out at a wavelength of approximately 227 nm, corresponding to the maximum absorbance of the phenolic chromophore of BPA. The injection volume will be 20 μL. Under these conditions, a symmetrical BPA peak with sufficient retention time and separation from interfering matrix components will be obtained. A calibration curve will be prepared based on BPA standards in the range of 0.1-50 μg/L, prepared in a solvent appropriate for the sample matrix. Peak areas will be analyzed relative to the standard concentrations, and linearity will be assessed using linear regression. The limit of detection (LOD) will be determined at a signal-to-noise ratio (S/N) of 3, and the limit of quantification (LOQ) at an S/N of 10. The method will be evaluated in terms of precision, accuracy, linearity, specificity, LOD/LOQ, and analyte recovery from the matrices.
baseline only
Food frequency intake
時間枠：From enrollment to the end of treatment at 6 months.
Food frequency intake will be assessed by using a validated questionnaire and will include questions concerning food groups with six possible answers: (1) never, (2) 1-3 times a month, (3) once a week, (4) 2-3 times a week, (5) once a day, (6) a few times during the day. Those responses will be converted into an average frequency of food intake per day [times per day].
From enrollment to the end of treatment at 6 months.
Nutrition intake
時間枠：From enrollment to the end of treatment at 6 months.
Nutrition intake will be assessed by three day dietary diary. The diary will be verified by the trained dietitian during the nutrition interview in lab of the Department of Human Nutrition and Dietetics, Poznan University of Life Sciences.
From enrollment to the end of treatment at 6 months.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

スポンサー

研究を開始し、研究に対する権限と管理権を持つ組織または個人。
Poznan University of Life Sciences

協力者

協力者

臨床研究を支援する治験依頼者以外の機関。このサポートには、資金調達、設計、実装、データ分析、またはレポートに関連する活動が含まれる場合があります。
IBIMA Plataforma BIONAD
ERA4Health: Modulation of brain ageing through nutrition and healthy lifestyle (NutriBrain)
Ecole Centrale Supélec
Flanders Research Institute for Agriculture, Fisheries and Food
ERA4Health
Narodowe Centrum Badań i Rozwoju

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

研究開始

最初の参加者が臨床試験に登録された実際の日付。 「予想される」研究開始日は、研究者が研究開始日になると考える日付です。
2026年5月1日

一次修了 (推定)

一次修了

臨床研究の最後の参加者が検査された、または主要な結果測定のための最終データを収集するための介入を受けた日付。治験がプロトコルに従って終了したか終了したかは、この日付には影響しません。完了日が異なる複数の主要評価項目を含む臨床研究の場合、この用語は、すべての主要評価項目のデータ収集が完了した日付を指します。 「予想される」一次完了日は、研究者がその研究の一次完了日になると考える日付です。
2027年4月30日

研究の完了 (推定)

研究の完了

臨床研究の最後の参加者が検査された、または介入/治療を受けて、主要な結果の尺度、副次的な結果の尺度、および有害事象の最終データを収集した日付 (つまり、最後の参加者の最後の訪問)。 「予想される」研究完了日は、研究者が研究完了日になると考える日付です。
2027年4月30日

試験登録日

最初に提出

最初に提出

治験依頼者または治験責任医師が初めて治験記録を ClinicalTrials.gov に提出した日付。通常、最初の提出日と ClinicalTrials.gov での記録の利用可能日 (最初の投稿日) の間には数日の遅延があります。
2026年3月25日

QC基準を満たした最初の提出物

QC基準を満たした最初の提出物

研究スポンサーまたは治験責任医師が、国立医学図書館 (NLM) の品質管理 (QC) 審査基準と一致する研究記録を最初に提出した日付。治験依頼者または研究者は、NLM の QC 審査基準が満たされるまでに、研究記録を 1 回または複数回修正して提出する必要がある場合があります。研究記録がNLM QC審査基準と一致していることを確認するのは、治験依頼者または治験責任医師の責任です。
2026年5月13日

最初の投稿 (実際)

最初の投稿

国立医学図書館 (NLM) の品質管理 (QC) レビューが終了した後、ClinicalTrials.gov で研究記録が最初に利用可能になった日付。通常、治験依頼者または治験責任医師が治験記録を提出した日と最初に投稿された日との間には数日の遅延があります。
2026年5月20日

学習記録の更新

投稿された最後の更新 (実際)

投稿された最後の更新

ClinicalTrials.gov で、研究記録が変更された最新の日付。研究のスポンサーまたは治験責任医師によって変更が ClinicalTrials.gov に提出されたとき (最終更新が提出された日) と最終更新が投稿された日との間に遅延が生じる場合があります。
2026年5月20日

QC基準を満たした最後の更新が送信されました

QC基準を満たした最後の更新が送信されました

治験依頼者または治験責任医師が、国立医学図書館（NLM）の品質管理（QC）審査基準と一致する治験記録の変更を提出した最新の日付。研究記録がNLM QC審査基準と一致していることを確認するのは、治験依頼者または治験責任医師の責任です。
2026年5月13日

最終確認日

最終確認日

治験依頼者または治験責任医師が、ClinicalTrials.gov で臨床治験に関する情報が正確かつ最新であることを確認した最新の日付。募集ステータスが募集中の研究の場合。まだ募集していません。過去 2 年以内に募集が確認されていない場合、研究の募集状況は不明として表示されます。
2026年3月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

その他の研究ID番号

NCT 番号以外の識別子または ID 番号で、治験依頼者、資金提供者、その他によって臨床治験に割り当てられたもの。これらの番号には、他の治験登録機関や国立衛生研究所の助成金番号からの一意の識別子が含まれる場合があります。
  • ERA4HEALTHNUTRIBRAIN-154

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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