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

N/ANot Yet RecruitingNCT07112248

Huazhong University of Science and Technology100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

100

Conditions

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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).