Genetic Markers Associated With Capsaicinoid Supplementation Effects in Overweight and Obesity
Identification of Genetic Markers Associated With the Effects of Capsaicinoid Supplementation on Appetite, Body Composition, Metabolic Profile, and Inflammatory Markers in Individuals With Overweight or Obesity
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
This study is a clinical investigation designed to understand how a natural compound found in chili peppers may influence the health of individuals with excess body weight, and why some people respond better than others to this type of intervention.
In recent years, it has been observed that certain compounds present in foods can affect metabolism-that is, how the body uses energy, regulates appetite, and stores fat. However, not all individuals respond in the same way to these compounds. This suggests that there are individual differences, possibly related to genetics, that may modify their effects.
The study will be conducted with a small group of adults with excess body weight, who will be randomly assigned to one of two groups. One group will receive daily supplementation with capsules containing an active compound derived from chili peppers, while the other group will receive identical capsules without the active ingredient (placebo). Neither the participants nor the researchers will know who receives which treatment during the study, helping to ensure more objective results.
The intervention will last 16 weeks, during which changes in body weight, body composition (such as fat mass), and metabolic health indicators such as blood glucose and lipid levels will be evaluated.
In addition to assessing the overall effects of the supplement, the study also aims to determine whether genetic characteristics can explain why some individuals show better responses than others. This could, in the future, support the development of more personalized dietary strategies tailored to each person's biological needs.
Overall, this research aims to contribute to the understanding of the potential of chili-derived compounds in supporting weight management, while also advancing toward a more personalized approach in nutrition and health.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Estado de Baja California
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Tijuana, Estado de Baja California, Meksyk
- Universidad Autonoma de Baja California
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adults diagnosed with overweight or obesity within the age range established for the study
- Willingness to participate in the study
- Signed informed consent form
Exclusion Criteria:
- History of thyroid or metabolic disorders requiring pharmacological treatment, such as diabetes mellitus or coronary heart disease
- Pregnant or breastfeeding women
- Active smokers
- High alcohol consumption, defined as >20 g/day in women and >40 g/day in men
- Use of hypocaloric diets or weight-loss medications within the three months prior to study initiation
- Daily chili consumption or high habitual intake of capsaicinoids
- Known hypersensitivity to capsaicinoids
- Gastrointestinal disorders, such as ulcerative colitis or irritable bowel syndrome
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Capsaicin supplementation (Capsipro)
Participants assigned to this group will receive capsaicin supplementation.
The dose will consist of two oral capsules per day, each containing 100 mg and standardized to 2% capsaicin, administered for 16 weeks.
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This intervention differs from similar studies due to the use of standardized capsaicin in fixed-dose capsules, rather than chili extracts, whole foods, or non-standardized mixtures.
It is also distinguished by a continuous daily administration regimen over 16 weeks, which allows the assessment of sustained effects over time on anthropometric and metabolic parameters under controlled conditions.
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Komparator placebo: Corn starch placebo
Participants assigned to this group will receive two oral capsules per day of a corn starch-based placebo, identical in appearance to the active treatment, administered for 16 weeks.
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Capsules indistinguishable from Capsipro, composed of corn starch, administered twice daily for 16 weeks
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in body fat percentage
Ramy czasowe: Baseline to 16 weeks
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Body fat percentage will be assessed using standardized body composition analysis methods to evaluate changes following capsaicinoid supplementation.
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Baseline to 16 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in appetite
Ramy czasowe: Baseline to 16 weeks
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Appetite will be assessed using the validated Simplified Nutritional Appetite Questionnaire (SNAQ). The SNAQ consists of 4 items with a total score ranging from 4 to 20 points, where higher scores indicate better appetite. |
Baseline to 16 weeks
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Change in body weight
Ramy czasowe: Baseline to 16 weeks
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Baseline to 16 weeks
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Concentration of fasting glucose, HDL, LDL, triglycerides, and other metabolic biomarkers
Ramy czasowe: Baseline to 16 weeks
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Fasting glucose, HDL, LDL, triglycerides and other metabolic biomarkers will be assessed through blood sample analysis.
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Baseline to 16 weeks
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Concentration of C-reactive protein (CRP) and other inflammatory biomarkers
Ramy czasowe: Baseline to 16 weeks
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Inflammatory biomarkers, including C-reactive protein (CRP) and other inflammatory indicators, will be assessed through blood sample analysis.
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Baseline to 16 weeks
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Genetic Risk Score for Capsaicinoid Response
Ramy czasowe: Baseline to 16 weeks
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A genetic risk score (GRS) will be calculated from genotype data obtained through molecular genetic analysis of blood samples. The score will be based on the presence of risk genotypes in rs4411417 and rs3783541 (GCH1); rs8065080, rs222747, rs224534, rs222749, and rs460716 (TRPV1); rs713598 and rs1726866 (TAS2R38); rs765007 (TAS2R3); rs2234001 (TAS2R4); and rs2234012 (TAS2R5), assuming additive and independent effects across all loci. The total score will represent the number of risk alleles/genotypes identified in each participant. |
Baseline to 16 weeks
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Współpracownicy i badacze
Publikacje i pomocne linki
Publikacje ogólne
- Liviero F, Campisi M, Scarpa MC, Mason P, Guarnieri G, Maestrelli P, Pavanello S. Multiple single nucleotide polymorphisms of the transient receptor potential vanilloid 1 (TRPV1) genes associate with cough sensitivity to capsaicin in healthy subjects. Pulm Pharmacol Ther. 2020 Apr;61:101889. doi: 10.1016/j.pupt.2020.101889. Epub 2020 Jan 11.
- Forstenpointner J, Forster M, May D, Hofschulte F, Cascorbi I, Wasner G, Gierthmuhlen J, Baron R. Short Report: TRPV1-polymorphism 1911 A>G alters capsaicin-induced sensory changes in healthy subjects. PLoS One. 2017 Aug 17;12(8):e0183322. doi: 10.1371/journal.pone.0183322. eCollection 2017.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 304/2/N/65/7
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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