Gut Microbiota, Obesity-related Poor Sperm Quality
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Maltodextrin
DIETARY_SUPPLEMENTinulin
Inulin is a kind of soluble dietary fiber.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male, aged 18-60 years； 2. Diagnostic criteria for obesity: BMI ≥ 28 kg/m² and body fat percentage ≥ 25%; 3. Semen samples can be collected, and sperm concentration \> 0.
Exclusion criteria
1. Spermatogenic dysfunction caused by non-obesity factors; 2. Severe systemic diseases such as cardiovascular/cerebrovascular, hepatic/renal disorders, malignant tumors, uncontrolled diabetes, or thyroid diseases; 3. Recent usage of medications/supplements affecting spermatogenesis or gut microbiota ; 4. Lifestyle factors potentially impairing sperm quality or severe gastrointestinal disorders; 5. Poor compliance, planned imminent fertility, or history of bariatric surgery/weight-loss medications; 6. Significant dietary changes within the past three months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The sperm quality of obese males | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the levels of sex hormones | Baseline, 4 weeks, 12 weeks | Changes in the levels of sex hormones, including Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Progesterone (P), Testosterone (T), and Prolactin (PRL). |
| Changes in sexual function | Baseline, 4 weeks, 12 weeks | The sexual function will be assessed by Brief Male Sexual Function Questionnaire. |
| Changes in DNA integrity of sperm | Baseline, 4 weeks, 12 weeks | Changes in the sperm DNA fragmentation index (DFI) will be measured by sperm chromatin structure assay (SCSA). |
| Changes in the gut microbiota | Baseline, 4 weeks, 12 weeks | Changes in the composition, diversity, and function of gut microbiota in feces will be measured by 16S rRNA gene sequencing. |
| Changes in the levels of bile acids in plasma | Baseline, 4 weeks, 12 weeks | Changes in the levels of bile acids in plasma will be evaluated by liquid chromatography-mass spectrometry (LC-MS). |
| 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 | — |
Countries
China
Outcome results
None listed