Obesity-related Poor Sperm QualityNCT07112248
Effects of Soluble Fiber Supplements on Sperm Quality in Males With Obesity: a Randomized Trial
A study testing inulin in people with Obesity-related Poor Sperm Quality and Gut Microbiota, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity-related Poor Sperm Quality, Gut Microbiota
- What is being tested?
- inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2025to 5 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Investigating the Effects of Soluble Dietary Fiber Supplements on Sperm Quality Parameters in Males With Obesity
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.
- Conditions
- Obesity-related Poor Sperm Quality, Gut Microbiota
- Being tested
- Placebo, inulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Maltodextrin
inulinDietary supplement
Inulin is a kind of soluble dietary fiber.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 15 g maltodextrin in a sachet once daily for 12 weeks. Receives: Dietary Supplement: Placebo |
| Soluble dietary fiber group | Experimental | 15 g inulin in a sachet once daily for 12 weeks. Receives: Dietary Supplement: inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks and 12 weeks.
Secondary outcomes (11)
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).
Measured: Baseline, 4 weeks, 12 weeks
Changes in sexual function
The sexual function will be assessed by Brief Male Sexual Function Questionnaire.
Measured: Baseline, 4 weeks, 12 weeks
Changes in DNA integrity of sperm
Changes in the sperm DNA fragmentation index (DFI) will be measured by sperm chromatin structure assay (SCSA).
Measured: Baseline, 4 weeks, 12 weeks
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.
Measured: Baseline, 4 weeks, 12 weeks
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).
Measured: Baseline, 4 weeks, 12 weeks
Changes in the levels of fasting plasma TC, TG, LDL, and HDL
Measured: Baseline, 4 weeks, 12 weeks
Change in body weight
Measured: Baseline, 4 weeks, 12 weeks
Change in BMI
Measured: Baseline, 4 weeks, 12 weeks
Change in waist-to-hip ratio (WHR)
Measured: Baseline, 4 weeks, 12 weeks
Change in body fat composition
Measured: Baseline, 4 weeks, 12 weeks
Change in the levels fasting plasma glucose
Measured: Baseline, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start10 Aug 2025
- Primary completion4 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity-related Poor Sperm QualityStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liegang Liu, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112248
- Sponsor's protocol ID
- XXM2025157
- Status last verified
- May 2026
- First submitted
- 2 Aug 2025
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Investigating the Effects of Soluble Dietary Fiber Supplements on Sperm Quality Parameters in Males With Obesity
- ClinicalTrials.gov ID
- NCT07112248
- Acronym / sponsor ID
- XXM2025157
- Conditions
- Obesity-related Poor Sperm Quality, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 4 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: Placebo15 g maltodextrin in a sachet once daily for 12 weeks. |
| Soluble dietary fiber group | Experimental | Dietary Supplement: inulin15 g inulin in a sachet once daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMaltodextrin | Dietary supplement | Control group |
| inulinInulin is a kind of soluble dietary fiber. | Dietary supplement | Soluble dietary fiber group |
Primary outcome
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.
11 secondary outcomes
Changes in the levels of sex hormones
Time frame: Baseline, 4 weeks, 12 weeks
Changes in sexual function
Time frame: Baseline, 4 weeks, 12 weeks
Changes in DNA integrity of sperm
Time frame: Baseline, 4 weeks, 12 weeks
Changes in the gut microbiota
Time frame: Baseline, 4 weeks, 12 weeks
Changes in the levels of bile acids in plasma
Time frame: Baseline, 4 weeks, 12 weeks
Changes in the levels of fasting plasma TC, TG, LDL, and HDL
Time frame: Baseline, 4 weeks, 12 weeks
Change in body weight
Time frame: Baseline, 4 weeks, 12 weeks
Change in BMI
Time frame: Baseline, 4 weeks, 12 weeks
Change in waist-to-hip ratio (WHR)
Time frame: Baseline, 4 weeks, 12 weeks
Change in body fat composition
Time frame: Baseline, 4 weeks, 12 weeks
Change in the levels fasting plasma glucose
Time frame: Baseline, 4 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inulin in people with Obesity-related Poor Sperm Quality and Gut Microbiota, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sperm quality of obese males (time frame: Baseline, 4 weeks and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.