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

Huazhong University of Science and Technology

Status: Not yet enrolling

Conditions: Gut Microbiota; Obesity-related Poor Sperm Quality

Treatments: Dietary Supplement: inulin; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07112248

XXM2025157

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Soluble dietary fiber group

Experimental group

Description:

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

Treatment:

Dietary Supplement: inulin