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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | 15 g maltodextrin in a sachet once daily for 12 weeks. |
|
| Soluble dietary fiber group | Experimental | 15 g inulin in a sachet once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Maltodextrin |
| |
| inulin |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 4 weeks, 12 weeks |
| Changes in sexual function |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hubei Maternal and Child Health Care Hospital | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Dietary Supplement |
Inulin is a kind of soluble dietary fiber. |
|
The sexual function will be assessed by Brief Male Sexual Function Questionnaire. |
| 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). | 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. | 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). | Baseline, 4 weeks, 12 weeks |
| Changes in the levels of fasting plasma TC, TG, LDL, and HDL | Baseline, 4 weeks, 12 weeks |
| Change in body weight | Baseline, 4 weeks, 12 weeks |
| Change in BMI | Baseline, 4 weeks, 12 weeks |
| Change in waist-to-hip ratio (WHR) | Baseline, 4 weeks, 12 weeks |
| Change in body fat composition | Baseline, 4 weeks, 12 weeks |
| Change in the levels fasting plasma glucose | Baseline, 4 weeks, 12 weeks |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |