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CompletedNCT07112248Updated May 18, 2026

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

An interventional study of Placebo and inulin in Obesity-related Poor Sperm Quality and Gut Microbiota, sponsored by Huazhong University of Science and Technology. Completed at 1 site in China. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by Huazhong University of Science and Technology · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Obesity-related Poor Sperm Quality
  • Gut Microbiota
03

In context

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
74 participants (actual)

Study arms

  • Placebo comparator
    Control group

    15 g maltodextrin in a sachet once daily for 12 weeks.

    Dietary Supplement: Placebo

  • Experimental
    Soluble dietary fiber group

    15 g inulin in a sachet once daily for 12 weeks.

    Dietary Supplement: inulin

Interventions

  • Dietary supplementPlacebo

    Maltodextrin

  • Dietary supplementinulin

    Inulin is a kind of soluble dietary fiber.

06

What researchers measure

Primary outcomes

  1. The sperm quality of obese males

    The sperm quality includes the motility, concentration and morphology of sperm and these parameters are all measured by Computer-Assisted Semen Analysis.

    Time frame: Baseline, 4 weeks and 12 weeks.

Secondary outcomes

  1. Changes in the levels of sex hormones

    Changes in the levels of sex hormones, including Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Progesterone (P), Testosterone (T), and Prolactin (PRL).

    Time frame: Baseline, 4 weeks, 12 weeks

  2. Changes in sexual function

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

    Time frame: Baseline, 4 weeks, 12 weeks

  3. Changes in DNA integrity of sperm

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

    Time frame: Baseline, 4 weeks, 12 weeks

  4. Changes in the gut microbiota

    Changes in the composition, diversity, and function of gut microbiota in feces will be measured by 16S rRNA gene sequencing.

    Time frame: Baseline, 4 weeks, 12 weeks

  5. Changes in the levels of bile acids in plasma

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

    Time frame: Baseline, 4 weeks, 12 weeks

  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

07

Study locations

1 site
  • Hubei Maternal and Child Health Care Hospital
    Wuhan, Hubei, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07112248
Lead sponsor
Huazhong University of Science and Technology
Responsible party
Liegang Liu (PhD, Huazhong University of Science and Technology) — Principal investigator
First posted
Aug 8, 2025
Start date
Aug 10, 2025
Primary completion
Jan 4, 2026
Completion
Jan 5, 2026
Last update
May 18, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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