Effects of Soluble Fiber Supplements on Sperm Quality in Males With Obesity: a Randomized Trial

Not Applicable

Not yet recruiting

• Conditions: Obesity-related Poor Sperm Quality; Gut Microbiota

• Registration Number: NCT07112248
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-02
• Study First Submitted QC: 2025-08-02
• Last Update Submitted: 2025-08-02
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Study Start: 2025-09-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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