Effects of Oral Sodium Butyrate Supplementation on Body Weight Reduction in Overweight/Obese Individuals With and Without Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Reduction in Body Weight After 12 Weeks of Oral Sodium Butyrate Supplementation Compared With Placebo
研究概览
简要总结
The goal of this clinical trial (randomized controlled trial with parallel group design) is to evaluate the effects of oral sodium butyrate supplementation for 12 weeks, compared with placebo, in addition to a moderately hypocaloric diet, on body weight, body composition, glucose metabolism, and lipid metabolism in overweight or obese individuals with and without type 2 diabetes.
The main questions this study aims to answer are:
- Does oral sodium butyrate improve body weight reduction and body composition compared with placebo?
- Does it improve glucose and lipid metabolism in participants with and without type 2 diabetes?
The study includes 46 men and women aged 30-70 years, with overweight or obesity (BMI 25-39.9 kg/m²) and HbA1c ≤ 7.0%. Participants are randomly assigned to receive either oral sodium butyrate or placebo, both combined with a moderately hypocaloric diet for 12 weeks.
Participants:
- Take sodium butyrate tablets (625 mg three times daily; total 1,875 mg/day) or placebo tablets with meals
- Follow a personalized, balanced hypocaloric diet monitored by a dietitian
- Attend clinic visits every two weeks for anthropometric measurements and dietary adherence checks
- Complete a 7-day food diary and a gastrointestinal symptom questionnaire (PAGI-SYM)
- Undergo fasting blood tests, body composition analysis (bioelectrical impedance), and continuous glucose monitoring (CGM) at baseline and after 12 weeks
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with overweight or obesity (Body Mass Index [BMI] between 25.0 and 39.9 kg/m²), with or without type 2 diabetes Age between 30 and 70 years HbA1c ≤ 7.5%
排除标准
- •Cardiovascular events (myocardial infarction and/or stroke) within the previous 6 months
- •Renal insufficiency (serum creatinine > 1.5 mg/dL) or hepatic impairment (ALT or AST levels more than twice the upper limit of normal)
- •Anemia (hemoglobin < 12 g/dL)
- •Insulin therapy or use of antihyperglycemic drugs other than metformin
- •Use of antibiotics, probiotics, or prebiotics within the previous 3 months
- •Habitual intense physical activity
- •Pregnancy or breastfeeding
结局指标
主要结局
Reduction in Body Weight After 12 Weeks of Oral Sodium Butyrate Supplementation Compared With Placebo
时间窗: baseline and 12 weeks
Body weight is measured at baseline and after 12 weeks of treatment. The primary outcome is the reduction in body weight (kg) from baseline to week 12 between the sodium butyrate and placebo groups.
次要结局
- Changes in Fasting Glucose(Baseline and 12 weeks)
- Changes in fasting insulin(Baseline and 12 weeks)
- Change in Body Composition (Fat Mass, Lean Mass, and Fat-Free Mass)(baseline and 12 weeks)
- Changes in Continuous Glucose Monitoring (CGM) Parameters(baseline and 12 weeks)
- Changes in glycated hemoglobin (HbA1c)(Baseline and 12 weeks)
- Changes in serum lipids(Baseline and 12 weeks)
- Changes in Short-Chain Fatty Acids (SCFA)(Baseline and 12 weeks)
- Changes in Intestinal Permeability Markers_Zonulin(Baseline and 12 weeks)
- Changes in Intestinal Permeability Markers_LPS(Baseline and 12 weeks)
- Changes in Inflammatory Markers_hsCRP(Baseline and 12 weeks)
- Changes in Gut Microbiota Composition(baseline and 12 weeks)
- Changes in Inflammatory Markers_TNFalfa_IL-6(Baseline and 12 weeks)
研究者
Giuseppina Costabile
Senior Researcher
Federico II University