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

NCT07112248 | Not Yet Recruiting

• 1 other identifier: XXM2025157
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

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.

  Baseline, 4 weeks and 12 weeks.

Secondary Outcomes (11)

• Changes in the levels of sex hormones

  Baseline, 4 weeks, 12 weeks

• Changes in sexual function

  Baseline, 4 weeks, 12 weeks

• Changes in DNA integrity of sperm

  Baseline, 4 weeks, 12 weeks

• Changes in the gut microbiota

  Baseline, 4 weeks, 12 weeks

• Changes in the levels of bile acids in plasma

  Baseline, 4 weeks, 12 weeks

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Soluble dietary fiber group

EXPERIMENTAL

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

Dietary Supplement: inulin

Interventions

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Control group

inulin DIETARY_SUPPLEMENT

Inulin is a kind of soluble dietary fiber.

Soluble dietary fiber group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

MeSH Terms

Interventions

Inulin

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Central Study Contacts

Liegang Liu, PhD

CONTACT

+86 27 83650522; lgliu@mails.tjmu.edu.cn

Lihui Shen

CONTACT

D202482056@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08