Microbiomes of Garden-fresh vs Store-bought Produce and Variation in Their Effects on the Human Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Difference in fecal microbial diversity, as characterized by shotgun metagenomics.
研究概览
简要总结
The purpose of this research is to explore what types of microbes are present on garden-fresh versus store-bought fruits and vegetables, as well as how they might affect the human gut microbiome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Body mass index (BMI) greater than or equal to 35 or less than or equal to
- •Age under 18 or over
- •Female who is pregnant or lactating.
- •Irregular bowel movements and/or stool consistency.
- •Plans to travel, move residences, or other major life change during the study period (August-October 2023).
- •Unable to speak, read, and write English.
- •Use of any of the following drugs within the last 6 months:
- •systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral);
- •oral, intravenous, intramuscular, nasal or inhaled corticosteroids;
- •cytokines;
- •methotrexate or immunosuppressive cytotoxic agents;
- •large doses of commercial probiotics consumed (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
- •Acute disease at the time of enrollment (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever.
- •History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
- •Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
- •Recent history of chronic alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day.
- •Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection.
- •Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
- •History of active uncontrolled gastrointestinal disorders or diseases including:
- •inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis;
- •irritable bowel syndrome (IBS) (moderate-severe);
- •persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated);
- •chronic constipation.
结局指标
主要结局
Difference in fecal microbial diversity, as characterized by shotgun metagenomics.
时间窗: Baseline, 1 week, 3 weeks
ANOVA statistical test of Shannon index used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal microbial diversity.
Presence of differentially abundant microbial taxa, as characterized by shotgun metagenomics.
时间窗: Baseline, 1 week, 3 weeks
Negative binomial GLM statistical test used to identify microbial taxa associated with either Garden-Fresh Produce or Supermarket Produce intervention.
Difference in fecal bacterial abundance, as characterized by qPCR with "universal" bacterial primers
时间窗: Baseline, 1 week, 3 weeks
ANOVA statistical test of bacterial gene copies (a proxy for absolute abundance) used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal bacterial abundance.
Difference in fecal microbial composition, as characterized by shotgun metagenomics.
时间窗: Baseline, 1 week, 3 weeks
PERMANOVA statistical test used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal microbial composition.
次要结局
未报告次要终点