Rekrutuje
Badanie kliniczne
Videolaryngoscopes in the Morbidly Obese
W Polsce: Wkrótce rekrutacjaNa świecie: Rekrutacja wkrótce
Otyłość: badanie kliniczne
Tytuł w rejestrze: Algal Lutein Against Decline of Intellectual Nimbleness
Najważniejsze informacje
- Choroba
- Otyłość, Menopauza (Menopausal Syndrome, Cognitive Decline, Obesity & Overweight, Menopause, Inflamation, Gut Dysbiosis, Bisphenol A, Cardio Vascular Disease)
- Status w Polsce
- Wkrótce rekrutacjarejestr nie podaje osobnego stanu dla Polski, pokazujemy stan całego badania
- Status na świecie
- Rekrutacja wkrótcestan całego badania w rejestrze
- Wiek uczestników
- 48-60 lat
- Płeć
- tylko kobiety
- Zdrowi ochotnicy
- tak
- Planowana liczba uczestników
- łącznie 300
- Terminy (planowane)
- 1 maja 2026 - 30 kwietnia 2027
- Kraje
- 1: Polska
- Numer w rejestrze
- NCT07600567 (ClinicalTrials.gov)
Gdzie prowadzone jest badanie
Ośrodki prowadzące badanie w Polsce (1), alfabetycznie według miejscowości:
- Faculty of Food Science and Nutrition, Poznan University of Life Sciences Wkrótce rekrutacjaPoznańKontakt
rekrutuje wkrótce nie rekrutuje lub brak danych
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Stan rekrutacji pochodzi z rejestrów badań i może się zmienić szybciej, niż zaktualizuje go sponsor. Nasz doradca sprawdzi aktualny stan w wybranym ośrodku. Nie publikujemy nazwisk lekarzy ani ich danych kontaktowych.
Cel badania
Opis z rejestru (w języku angielskim):
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.
Leczenie w badaniu
| Lek / interwencja | Rola | Postać, podanie |
|---|---|---|
| Lutein | Suplement | |
| Placebo | Inne |
Kryteria udziału
Kryteria w języku angielskim, tak jak w rejestrze.
Kryteria włączenia kto może wziąć udział (4)
- Females
- Age 48-60 years
- Postmenopausal status (natural menopause, up to 5 years after menopause)
- waist circumference ≥ 88 cm
Kryteria wyłączenia kto nie może wziąć udziału (8)
- 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
To główne kryteria z rejestru. Pełną listę i ostateczną decyzję o udziale ustala lekarz prowadzący badanie.
Zapytaj o udział w tym badaniu
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Zadzwoń do naszego specjalisty+48 664 930 800pon-pt: 9:00 - 18:00
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Informacje pochodzą z publicznych rejestrów badań klinicznych (CTIS - Unia Europejska, ClinicalTrials.gov - USA) i są aktualizowane codziennie. Mogą różnić się od aktualnego stanu w ośrodku. Ostateczną kwalifikację do badania zawsze przeprowadza lekarz w ośrodku badawczym. Stan na 2 października 2026.