Effect of Plant-based Diet on Cardiometabolic and Inflammatory Parameters in Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Th17/ Treg ratio
研究概览
简要总结
The goal of this clinical trial is to evaluate cardiometabolic and inflammatory parameters in kidney transplant recipients after transitioning to a plant-based diet (PBD). The main aims of the study are as follows:
- To test the feasibility of transiting renal allograft recipients who are > 3 months post-transplant to a PBD
- To study the effect of a PBD on cardiometabolic parameters in kidney transplant recipients
- To assess the effect of a PBD on peripheral blood Th17/Treg ratio and systemic inflammation in kidney transplant recipients
Participants will be asked to:
- Complete a 2-week investigator-designed PBD transition program
- Follow a PBD for a minimum of 16 weeks
- Consent for blood draws, urine samples, and fecal samples along with physical exams
- Complete intermittent food frequency questionnaires and quality of life questionnaires
- Periodically meet with investigators and other study participants
Researchers will compare baseline measurements with future measurements for each participant.
详细描述
Patients will initially be identified through electronic medical record screening.
Eligible patients will be approached in clinic and informed about the study. Patients who agree to participate will sign the informed consent document to complete enrollment.
Phase 1: Dietary Training (weeks 1-2). Patients receive instruction from a Nephrologist, who is experienced in PBDs and medical student investigators about transitioning to a plant-based diet. Patients will complete a 2 week training program consisting of presentations, videos, informational documents, and group sessions. The program is designed such that at the 2 week point, participants will feel comfortable purchasing, cooking, and eating plant-based foods.
Phase 2: Intervention (weeks 3-18). Patients will consume a PBD under supervision for 16 weeks. Each participant will receive weekly phone calls from the study team and there will be monthly large in-person group sessions.
During Phase 2, there will be an optional, but highly recommended, in person group session that occurs every month. These sessions are designed to facilitate conversations and connections between participants. The sessions will help create a sense of community amongst participants. The group sessions will entail answering participants' questions, having discussions about challenges, and breakout groups will be used so participants can talk in a smaller group environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
There will be no masking.
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
- 否
入选标准
- •> 3 months post-kidney transplant
- •On style immunosuppressive medication
- •Without evidence of active infection/ inflammatory conditions
- •Estimated glomerular filtration rate > 45ml/min/1.73 m^2
- •English speaking
- •Reliable internet access
排除标准
- •Acute/ chronic allograft rejection
- •History of non-compliance
- •Advance heart failure
- •Liver disease
- •Pregnancy
- •Malignancy
- •Chronic Infection
- •Currently following a plant-based diet
研究组 & 干预措施
Plant-based diet
The group will follow a plant-based diet. Compliance will be checked with dietary questionnaires.
干预措施: Plant-based diet (Behavioral)
结局指标
主要结局
Th17/ Treg ratio
时间窗: Baseline, week 10, 18, 26
Th17/Treg cell ratio in peripheral blood. Results expressed as cell frequencies
Interleukin (IL) Levels (IL-6, IL-17, IL-21)
时间窗: Baseline, week 10, 18, 26
Plasma levels measured using ELISA expressed as units/ mL
Weight
时间窗: Baseline, week 10, 18, 26
Kilograms
Anthropometry
时间窗: Baseline, week 18, 26
Mid arm and abdominal circumference will be measured in centimeters
Blood pressure
时间窗: Baseline, week 10, 18, 26
Systolic blood pressure (mmHg)/ Diastolic blood pressure (mmHg)
HbA1c
时间窗: Baseline, week 10, 18, 26
mmol/mol and percent (percent of total hemoglobin)
Non-fasting blood glucose
时间窗: Baseline, week 10, 18, 26
mg/dL
Total cholesterol
时间窗: Baseline, week 10, 18, 26
mg/dL
hsCRP
时间窗: Baseline, week 10, 18, 26
Plasma levels measured using enzyme-linked immunosorbent assay (ELISA) expressed as units/ mL
BMI
时间窗: Baseline, week 10, 18, 26
Weight in kilograms (kg) and height (m) in meters will be combined to report BMI kg/m\^2
Food frequency questionnaire
时间窗: Baseline, week 18, 26
Nutrient intake and physical activity levels will be calculated
Weekly one day food recall
时间窗: Once per week at baseline and weeks 3-18
Dietary compliance will be measured with weekly one day food recall. The percentage of total daily food that is whole food plant-based will be calculated
次要结局
- Creatinine(Baseline, week 10, 18, 26)
- Low-density lipoprotein (LDL) cholesterol(Baseline, week 10, 18, 26)
- High-density lipoprotein (HDL) cholesterol(Baseline, week 10, 18, 26)
- Estimated glomerular filtration rate(Baseline, week 10, 18, 26)
- Kidney disease and quality of life (KDQOL-36)(Baseline, week 18, 26)
- Triglycerides(Baseline, week 10, 18, 26)
- Changes in gut microbiome(Baseline, week 18, 26)
研究者
Muralidharan Jagadeesan
Principal Investigator
George Washington University