The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic Patients: A Double Blinded Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Glycemic markers
研究概览
简要总结
This is a randomized controlled trial that will be conducted on Saudi prediabetic and diabetic adults aged 18 to 70 years. The aim of the study is to investigate the effect of synbiotic consumption on gut microbiome, glycemic control, and other diabetes-related outcomes in patients with prediabetes and diabetes. A total of 160 participants will be recruited from King Fahd Hospital of the University, Eastern Province, Saudi Arabia and randomly assigned to synbiotic group (prediabetic and diabetic, n=40 each group) or control group (prediabetic and diabetic, n=40 each group) for a 6-month trial. A structured questionnaire will be used for data collection from subjects. The questionnaire will include data related to socioeconomic status, health and diet related history. Primary outcomes including gut microbiome sequencing, glycemic control related parameters and secondary outcomes including inflammatory markers, food intolerance and anthropometric measurements will be measured before the study, after 3 months and after 6 months. The findings of the current study will shed light on the significance of synbiotic consumption on glycemic control and other diabetes-related outcomes and their relation to food allergy and autoimmunity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with type 1 diabetes
- •Patients on insulin therapy
- •Patients on antibiotics
- •Pregnant and lactating women
- •Smoking individuals
- •Patients with comorbidities (except for hyperlipidemia and blood pressure)
- •Patients taking immunosuppressants
- •Patients taking probiotics, prebiotics or synbiotics
排除标准
- •Patients with prediabetes (HbA1c of 5.7- 6.4% or a fasting plasma glucose of 100 -125 mg/dl)
- •Patients with type 2 diabetes (HbA1c of ≥ 6.5% or a fasting plasma glucose of ≥ 126 mg/dl
- •Male and female patients aged (18-70) years
- •Patients with HbA1c of ≥ 5.7 or a fasting plasma glucose of ≥100 mg/dl
结局指标
主要结局
Glycemic markers
时间窗: 6 months
HbA1c, FBG (through blood samples)
Inflammatory markers
时间窗: 6 months
IL-1, IL-10, CRP, IFN-γ (through blood samples)
Body Composition parameters
时间窗: 6 months
Muscle mass, Fat mass (through a body composition analyzer)
BMI
时间窗: 6 months
Height and weight will be measured to obtain BMI (kg/m2)
Waist circumference
时间窗: 6 months
in (cm) by a measurement tape
次要结局
- Microbiome sequencing(6 months)
研究者
Razan Algarni
Principal investigator
Imam Abdulrahman Bin Faisal University