Diet and the Colonic Exfoliome: A Novel, Non-Invasive Approach to Testing Interventions in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators)
研究概览
简要总结
This trial studies how fiber and fish oil supplements affect the metabolism and activities of colon cells in healthy individuals. Diet is an important risk factor for colorectal cancer, and several dietary components important in colorectal cancer prevention are modified by gut microbial metabolism. Giving fiber and fish oil supplements may inhibit the growth of gut cells and ultimately reduce risk of colorectal cancer.
详细描述
Participants are randomized to receive two dietary interventions in assigned random order. They either receive the dietary fiber supplement and fish oil supplement orally (PO) daily or they receive a fiber control and corn oil supplement daily for 30 days during the first intervention period. Then they enter a washout period for 60 days when they do not receive any treatment. After that they complete the second intervention period during which they receive the other intervention.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal-overweight (body mass index [BMI] of 18-30 kg/m^2)
- •Women will be postmenopausal, with no menstrual period in 12 months
- •Non-smoking
- •Consume fiber intakes of less than < 20 g/d
- •White blood cell count 3,000-11,000/mm^3
- •Platelet count 100,000-400,000 mm^3
- •Hematocrit 33-50% (women); 36-50% (men)
- •Bilirubin 0.2-1.3 mg/dL
- •Aspartate aminotransferase (AST) 0-35 U/L
- •Alanine aminotransferase (ALT) 0-40 U/L
- •Alkaline phosphatase 20-125 U/L
- •Creatinine =< 1.2 mg/dL
- •Potassium 3.5-5.0 mmol/L
排除标准
- •Chronic medical illness, history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, hereditary nonpolyposis colorectal cancer [HNPCC], familial adenomatous polyposis, pancreatic disease, previous gastrointestinal resection, radiation or chemotherapy, and cancer (other than non-melanoma skin cancer)
- •Weight change greater than 4.5 kg within past year
- •Oral or intravenous (IV) antibiotic use within the past 3 months
- •Regular use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Smoking or use of cannabis products
- •Known allergy to fish
- •Intention to relocate out of study area within next 4 months
研究组 & 干预措施
Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator
Participants first received a fiber supplement and a fish oil supplement PO daily for 30 days (Period 1). Participants entered a washout period for at least 60 days. For period 2 they received similarly packaged comparator (maltodextrin and corn oil)
干预措施: Dietary Fiber (Dietary Supplement)
Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator
Participants first received a fiber supplement and a fish oil supplement PO daily for 30 days (Period 1). Participants entered a washout period for at least 60 days. For period 2 they received similarly packaged comparator (maltodextrin and corn oil)
干预措施: Comparator (Other)
Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil
Participants first received the comparator (maltodextrin and corn oil) supplement PO daily for 30 days (Period 1). Participants enter a washout period for at least 60 days. For period 2 they received the fiber supplement and a fish oil supplement
干预措施: Dietary Fiber (Dietary Supplement)
Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil
Participants first received the comparator (maltodextrin and corn oil) supplement PO daily for 30 days (Period 1). Participants enter a washout period for at least 60 days. For period 2 they received the fiber supplement and a fish oil supplement
干预措施: Comparator (Other)
Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil
Participants first received the comparator (maltodextrin and corn oil) supplement PO daily for 30 days (Period 1). Participants enter a washout period for at least 60 days. For period 2 they received the fiber supplement and a fish oil supplement
干预措施: Fish Oil (Dietary Supplement)
Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator
Participants first received a fiber supplement and a fish oil supplement PO daily for 30 days (Period 1). Participants entered a washout period for at least 60 days. For period 2 they received similarly packaged comparator (maltodextrin and corn oil)
干预措施: Fish Oil (Dietary Supplement)
结局指标
主要结局
Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators)
时间窗: Baseline to completion of the 2 study time periods
This grant is an R21 with the intent to provide preliminary data to propose a trial with a larger sample size and adequate statistical power.
次要结局
- Number of Differentially Expressed Exfoliome Genes at p<0.01(End of Fiber Plus Fish Oil Supplementation vs end of Comparator)
- Compliance(Average at the end of each intervention period)
研究者
Johanna Lampe
Professor
Fred Hutchinson Cancer Center