A Randomized Controlled Trial Investigating the Effects of Soluble Dietary Fiber Supplements on Sperm Quality Parameters in Males With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- The sperm quality of obese males
研究概览
简要总结
Obesity-related poor sperm quality is a significant public health issue, acting as a major contributor to male infertility. Dietary intervention has emerged as an effective strategy to manage obesity and improve sperm quality. Soluble dietary fiber (SDF), an essential nutritional component, plays a crucial role in regulating host health. Notably, insufficient SDF intake has been associated with both obesity and low sperm motility. However, the effect of SDF supplementation on sperm quality in males with obesity remains unclear. Thus, we conducted a randomized, placebo-controlled study to investigate the effect of SDF supplementation on sperm quality in males with obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, aged 18-60 years；
- •Diagnostic criteria for obesity: BMI ≥ 28 kg/m² and body fat percentage ≥ 25%;
- •Semen samples can be collected, and sperm concentration > 0.
排除标准
- •Spermatogenic dysfunction caused by non-obesity factors;
- •Severe systemic diseases such as cardiovascular/cerebrovascular, hepatic/renal disorders, malignant tumors, uncontrolled diabetes, or thyroid diseases;
- •Recent usage of medications/supplements affecting spermatogenesis or gut microbiota ;
- •Lifestyle factors potentially impairing sperm quality or severe gastrointestinal disorders;
- •Poor compliance, planned imminent fertility, or history of bariatric surgery/weight-loss medications;
- •Significant dietary changes within the past three months.
研究组 & 干预措施
Control group
15 g maltodextrin in a sachet once daily for 12 weeks.
干预措施: Placebo (Dietary Supplement)
Soluble dietary fiber group
15 g inulin in a sachet once daily for 12 weeks.
干预措施: inulin (Dietary Supplement)
结局指标
主要结局
The sperm quality of obese males
时间窗: Baseline, 4 weeks and 12 weeks.
The sperm quality includes the motility, concentration and morphology of sperm and these parameters are all measured by Computer-Assisted Semen Analysis.
次要结局
- Changes in the levels of sex hormones(Baseline, 4 weeks, 12 weeks)
- Changes in sexual function(Baseline, 4 weeks, 12 weeks)
- Changes in DNA integrity of sperm(Baseline, 4 weeks, 12 weeks)
- Changes in the gut microbiota(Baseline, 4 weeks, 12 weeks)
- Changes in the levels of bile acids in plasma(Baseline, 4 weeks, 12 weeks)
- Changes in the levels of fasting plasma TC, TG, LDL, and HDL(Baseline, 4 weeks, 12 weeks)
- Change in body weight(Baseline, 4 weeks, 12 weeks)
- Change in BMI(Baseline, 4 weeks, 12 weeks)
- Change in waist-to-hip ratio (WHR)(Baseline, 4 weeks, 12 weeks)
- Change in body fat composition(Baseline, 4 weeks, 12 weeks)
- Change in the levels fasting plasma glucose(Baseline, 4 weeks, 12 weeks)
研究者
Liegang Liu
PhD
Huazhong University of Science and Technology