Dietary Impact on Intestinal Sulfate Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production
研究概览
简要总结
This is a 5-week crossover pilot study of 15 highly motivated healthy volunteers who will consume two 7-day intervention diets: 1) a diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources; and 2) a diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources. A 14-day washout period will follow each intervention, in which participants will eat their typical diets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide informed consent
- •Ambulatory and community dwelling
- •Able and willing to comply with the study schedule and procedures
- •18 - 80 years of age
- •BMI between 18.5 - 40.0 kg/m2
- •Omnivorous or willing to consume animal products through duration of study
排除标准
- •Antibiotic use within 3 months
- •Planned antibiotic therapy within the period of the study, e.g., perioperative antibiotics.
- •Use of sulfonamides or sulfasalazine, as these sulfur-containing medications may confound results
- •Use of 5-aminosalicylates (5-ASA), as they are known to inhibit sulfidogenesis
- •History of anaphylactic food allergies, e.g., peanuts, seafood.
- •Food intolerances and allergies, including gluten sensitivity, lactose intolerance, and intolerance of high fiber dietary content.
- •Strict vegan eating practices, with refusal to consume animal products.
- •Planned use of oral probiotics while on study.
- •Serious, concomitant illness that, in the opinion of the Investigator, would interfere with evaluation of safety or efficacy, or put the participant at risk of harm from study participation.
- •Significant alcohol use, defined as > 20 g/day in females and > 30 g/day in males for a period of 3 months within one year prior to screening.
- •Underlying chronic gastrointestinal disease that can cause diarrhea, including short bowel syndrome, irritable bowel syndrome, malabsorption, and celiac disease.
- •History of partial or complete colectomy.
- •History of malabsorptive bariatric surgery.
- •Currently participating in another clinical study.
- •Legally incompetent and unable to understand the study's purpose, significance and consequences, and to make decisions accordingly.
结局指标
主要结局
Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production
时间窗: Following 1-week of plant- and animal-based eating patterns
Determine the effect of short-term (1-week) plant- and animal-based eating patterns on ex vivo fecal hydrogen sulfide production in healthy human volunteers We will measure fecal hydrogen sulfide production ex vivo in ppm/g of dry weight of stool
次要结局
未报告次要终点