The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Colonic inflammation
研究概览
简要总结
The goal of this clinical trial is to learn if changing cysteine levels in the diet can influence how the body processes cysteine in Black and White individuals aged 45-75 with a history of non-cancerous polyps. The main questions it aims to answer are:
- At the beginning of the study, do Black participants have higher levels of cortisol (a stress hormone) and compounds made from cysteine in their blood when compared to White participants?
- Does eating less cysteine lower the body's natural cysteine activity and lead to less gut bacteria that break down cysteine?
- Does eating less cysteine lead to less inflammation in the gut and lower levels of markers of inflammation in the blood?
Research will compare a high cysteine diet and a low cysteine diet, and each participant will eat both diets.
Participants will be in the study for 11 weeks and 2 days. Over the course of the study, participants will:
- Eat a high cysteine diet for 3 weeks, and a low cysteine diet for 3 weeks
- Eat a moderate cysteine diet for 1 week before each study diet
- Complete surveys
- Provide blood, stool, and saliva samples
- Maintain food logs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 45-75
- •Up to date with CRC screening colonoscopy with a high risk of CRC, defined as a history of 3 or more adenomatous polyps (APs) or an AP >1 cm in the past 5 years
- •Identify as Black or Non-Hispanic White
- •If female, no menstrual period for at least six months
- •Willingness to donate oral wash and stool samples
- •Willingness to complete 24-hour dietary recalls
排除标准
- •Antibiotic use within the last 6 months
- •Abnormal gastrointestinal transit
- •A history of organ transplantation
- •Use of illicit drugs, combustible tobacco, or dietary supplements
- •Pre- or probiotics within the last two months
- •A history of cancer treatment within the past 12 months
- •CRC or a genetic predisposition to CRC
- •A baseline body weight > 450 lbs
- •Weight gain or loss > 4 kg 3 months prior to study
- •Significant food allergies, food preferences or therapeutic or vegetarian diets
- •Menstrual cycle within the last 6 months
- •Antibiotics in the last 2 months
- •Cannot keep a food record for 7 consecutive days during screening after detailed instruction
- •Significant medical conditions
- •History of eating disorders
- •Alcoholism
- •Individuals under the age of 18
研究组 & 干预措施
Low cysteine diet
Participants will eat a diet lower in cysteine, relying on more plant based protein.
干预措施: Low Cysteine Diet (Other)
High cysteine diet
Participants will eat a diet higher in cysteine, relying on more animal based protein.
干预措施: High Cysteine Diet (Other)
结局指标
主要结局
Colonic inflammation
时间窗: Baseline, Week 1 (Day 8), Week 2 (Day 15), Week 4 (Day 29), Week 7 (Day 49), Week 8 (Day 57), Week 9 (Day 64), Week 11 (Day 78)
Fecal calprotectin, a marker of intestinal inflammation, will be measured from 100 mg of stool collected at the respective timeframe using a CALPRO Calprotectin ELISA test.
Fecal microbial content
时间窗: Baseline, Week 1 (Day 8), Week 2 (Day 15), Week 4 (Day 29), Week 7 (Day 49), Week 8 (Day 57), Week 9 (Day 64), Week 11 (Day 78)
Microbial genomic DNA will be extracted from stool obtained at the respective timeframe using a Qiagen DNeasy PowerSoil Kit. Genomic DNA will be fragmented using a Covaris S2 and processed into libraries using an Integrated DNA Technologies xGen DNA Library Prep Kit. Final libraries will be pooled and sequenced on an Illumina NovaSeq X using 25B chemistry.
Systemic markers of inflammation
时间窗: Baseline, Week 1 (Day 9), Week 2 (Day 16), Week 3 (Day 23), Week 4 (Day 30), Week 7 (Day 50), Week 8 (Day 58), Week 9 (Day 65), Week 11 (Day 79)
Serum from blood collected at the respective timeframe will be analyzed in triplicate with the Bio-Plex® Precision Pro™ (Bio rad, Hercules, CA) human cytokine 10-plex immunoassay to detect IL-1β, IL-6, IFN-γ, TNF-α, IL-2, IL-4, IL-5, IL-10, IL-12 (p70) and IL-13.
Colonic inflammation
时间窗: Baseline, Week 1 (Day 8), Week 2 (Day 15), Week 4 (Day 29), Week 7 (Day 49), Week 8 (Day 57), Week 9 (Day 64), Week 11 (Day 78)
Fecal calprotectin, a marker of intestinal inflammation, will be measured from 100 mg of stool collected at the respective timeframe using a CALPRO Calprotectin ELISA test.
Fecal microbial content
时间窗: Baseline, Week 1 (Day 8), Week 2 (Day 15), Week 4 (Day 29), Week 7 (Day 49), Week 8 (Day 57), Week 9 (Day 64), Week 11 (Day 78)
Microbial genomic DNA will be extracted from stool obtained at the respective timeframe using a Qiagen DNeasy PowerSoil Kit. Genomic DNA will be fragmented using a Covaris S2 and processed into libraries using an Integrated DNA Technologies xGen DNA Library Prep Kit. Final libraries will be pooled and sequenced on an Illumina NovaSeq X using 25B chemistry.
Systemic markers of inflammation
时间窗: Baseline, Week 1 (Day 9), Week 2 (Day 16), Week 3 (Day 23), Week 4 (Day 30), Week 7 (Day 50), Week 8 (Day 58), Week 9 (Day 65), Week 11 (Day 79)
Serum from blood collected at the respective timeframe will be analyzed in triplicate with the Bio-Plex® Precision Pro™ (Bio rad, Hercules, CA) human cytokine 10-plex immunoassay to detect IL-1β, IL-6, IFN-γ, TNF-α, IL-2, IL-4, IL-5, IL-10, IL-12 (p70) and IL-13.
次要结局
- Quantification of serum hydroxycortisol and cysteine metabolism markers(Baseline, Week 1 (Day 9), Week 2 (Day 16), Week 3 (Day 23), Week 4 (Day 30), Week 7 (Day 50), Week 8 (Day 58), Week 9 (Day 65), Week 11 (Day 79))
- Absolute and relative quantification of microbial cysteine metabolic genes(Baseline, Week 1 (Day 8), Week 2 (Day 15), Week 4 (Day 29), Week 7 (Day 49), Week 8 (Day 57), Week 9 (Day 64), Week 11 (Day 78))
- Whole body composition(Baseline, Week 4 (Day 30), Week 11 (Day 79))
- Exfoliated intestinal epithelial cell transcriptomics(Baseline, Week 1 (Day 8), Week 4 (Day 29), Week 8 (Day 57), Week 11 (Day 78))
- Quantification of serum hydroxycortisol and cysteine metabolism markers(Baseline, Week 1 (Day 9), Week 2 (Day 16), Week 3 (Day 23), Week 4 (Day 30), Week 7 (Day 50), Week 8 (Day 58), Week 9 (Day 65), Week 11 (Day 79))
- Absolute and relative quantification of microbial cysteine metabolic genes(Baseline, Week 1 (Day 8), Week 2 (Day 15), Week 4 (Day 29), Week 7 (Day 49), Week 8 (Day 57), Week 9 (Day 64), Week 11 (Day 78))
- Whole body composition(Baseline, Week 4 (Day 30), Week 11 (Day 79))
- Exfoliated intestinal epithelial cell transcriptomics(Baseline, Week 1 (Day 8), Week 4 (Day 29), Week 8 (Day 57), Week 11 (Day 78))
研究者
Patricia Wolf
Dr. Patricia Wolf, Assistant Professor, Department of Nutrition Science
Purdue University