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

NCT ID: NCT07112248

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-06-30

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.

Conditions

Obesity-related Poor Sperm Quality; Gut Microbiota

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

Soluble dietary fiber group

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

Group Type: EXPERIMENTAL

inulin

Intervention Type: DIETARY_SUPPLEMENT

Inulin is a kind of soluble dietary fiber.

Interventions

Placebo

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

inulin

Inulin is a kind of soluble dietary fiber.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Liegang Liu

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Liegang Liu, PhD

Role: CONTACT

lgliu@mails.tjmu.edu.cn

+86 27 83650522

Lihui Shen

Role: CONTACT

D202482056@hust.edu.cn

Other Identifiers

XXM2025157

Identifier Type: -

Identifier Source: org_study_id