Impact of High Dietary Fiber on Microbiome and Vaccine Responses
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Feasibility of dietary intervention prior to seasonal influenza vaccination defined as ≥ 80% of subjects being compliant with the intervention in the cohort
研究概览
简要总结
To learn if diet can enhance the microbes (such as bacteria and viruses) found in your gut and improve the body's immune response to the influenza (flu) vaccine.
详细描述
Primary Objectives:
--To determine the feasibility of two dietary intervention strategies focused on fiber-rich and prebiotic foods prior to seasonal influenza vaccination. Feasibility is defined as ≥ 80% of subjects being compliant with the intervention.
Secondary Objectives:
- To evaluate the effects of each dietary intervention on the composition, diversity and function of the gut microbiome.
- To assess the effects of each dietary intervention on response to influenza vaccination as measured by vaccine-specific immune response.
- To assess the effects of each dietary intervention on systemic immunity.
Exploratory Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •MD Anderson employees with existing MRNs
- •Body Mass Index (BMI) 18.5-40 kg/m2
- •Age 18 or older
- •Intends to receive the seasonal influenza vaccine at MD Anderson through Employee Health (starting Fall of 2022)
- •Willing to adhere to the provided dietary interventions
- •Willing to provide blood and stool specimens, complete diet questionnaires and logs, and pick up food on-site within the study schedule
- •English-speaking
- •Has easy access to a scale at home, work, or in their community
排除标准
- •Contraindication to the recommended annual influenza vaccine
- •Medical contraindications to the intervention diet
- •Major dietary restrictions (including vegetarian or vegan diets) or food allergies
- •Unable or unwilling to undergo study procedures
- •Has diabetes mellitus requiring medical treatment
- •Has inflammatory bowel disease
- •Has a history of bariatric surgery
- •Has a history of major gastrointestinal surgery (not including appendectomy or cholecystectomy)
- •Antibiotic use within 30 days of study initiation or planned antibiotic treatment during study course
- •Habitual consumption of a high fiber diet
- •Use of a supplement containing fiber/prebiotics/probiotics within 30 days of study initiation
- •Women who are pregnant, planning to become pregnant, or who are lactating may not be included in this study
研究组 & 干预措施
Prebiotic Food-Enriched Diet (PreFED) Intervention
Participants are expected to incorporate study snacks and meal components provided into your usual diet.
干预措施: Prebiotic Food-Enriched Diet (PreFED) (Dietary Supplement)
High-Fiber Diet (HFD) Intervention
Participants are expected to eat only the study meals and snacks provided
干预措施: High-Fiber Diet (HFD) (Dietary Supplement)
结局指标
主要结局
Feasibility of dietary intervention prior to seasonal influenza vaccination defined as ≥ 80% of subjects being compliant with the intervention in the cohort
时间窗: through study completion an average of 1 year.
次要结局
未报告次要终点