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
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Estado de Baja California
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Tijuana, Estado de Baja California, Мексика
- Universidad Autonoma de Baja California
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: 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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Плацебо Компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in body fat percentage
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in appetite
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 304/2/N/65/7
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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