Skip to main content
OpenTrials
Completed

NCT Number: NCT07112248

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity-related Poor Sperm Quality Gut Microbiota

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hubei Maternal and Child Health Care Hospital

Wuhan, Hubei, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Placebo

Dietary Supplement

Maltodextrin

Inulin

Dietary Supplement

Inulin is a kind of soluble dietary fiber.

Primary outcomes

  1. The sperm quality of obese males

    Time frame: 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 outcomes

  1. Changes in the levels of sex hormones

    Time frame: 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).

  2. Changes in sexual function

    Time frame: Baseline, 4 weeks, 12 weeks

    The sexual function will be assessed by Brief Male Sexual Function Questionnaire.

  3. Changes in DNA integrity of sperm

    Time frame: Baseline, 4 weeks, 12 weeks

    Changes in the sperm DNA fragmentation index (DFI) will be measured by sperm chromatin structure assay (SCSA).

  4. Changes in the gut microbiota

    Time frame: 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.

  5. Changes in the levels of bile acids in plasma

    Time frame: Baseline, 4 weeks, 12 weeks

    Changes in the levels of bile acids in plasma will be evaluated by liquid chromatography-mass spectrometry (LC-MS).

  6. Changes in the levels of fasting plasma TC, TG, LDL, and HDL

    Time frame: Baseline, 4 weeks, 12 weeks

  7. Change in body weight

    Time frame: Baseline, 4 weeks, 12 weeks

  8. Change in BMI

    Time frame: Baseline, 4 weeks, 12 weeks

  9. Change in waist-to-hip ratio (WHR)

    Time frame: Baseline, 4 weeks, 12 weeks

  10. Change in body fat composition

    Time frame: Baseline, 4 weeks, 12 weeks

  11. Change in the levels fasting plasma glucose

    Time frame: Baseline, 4 weeks, 12 weeks

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

A Randomized Controlled Trial Investigating the Effects of Soluble Dietary Fiber Supplements on Sperm Quality Parameters in Males With Obesity

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.