The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
Obesity, defined by WHO standards as having a body mass index (BMI) equal to or greater than 30 kg/m², affects approximately 800 million people worldwide. It is evident that obesity has become a serious public health issue, resulting in significant health burdens.
Previous systematic reviews have indicated an association between obesity and male factor infertility. In populations undergoing assisted reproductive technology (ART), some studies have shown a correlation between increased male BMI and adverse ART outcomes. Furthermore, the negative effects of obesity may also be transmitted to offspring through genetic and epigenetic changes in reproductive cell DNA, increasing their risk of obesity, metabolic diseases, or other chronic conditions.
Currently, there is a lack of data on the impact of weight loss in obese men on fertility, and it is unclear which nutritional pattern in lifestyle interventions can more effectively control weight, improve semen quality, and address related endocrine issues in obese men, thereby improving reproductive treatment outcomes.
Based on previous literature, we hypothesize that lifestyle interventions, particularly strict low-carbohydrate diets combined with lifestyle guidance, may offer greater health benefits for obese men. These benefits include effective weight loss, improvement in semen parameters, reproductive metabolic health, quality of life related to reproductive health, and the impact on reproductive treatment outcomes. This provides a basis for non-pharmacological intervention strategies and methods for the health of obese men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Based on the design of this clinical trial, blinding is not implement ed for participants and care providers. Blinding is only applied to outcome assessors and investigators. Outcome assessors are clinical staff members who are unaware of the group assignments, and data is collected directly from the medical records system by EDC data entry personnel for management (double-checking). Data analysts will directly extract information and data from the EDC database for statistical analysis. Blinding will be revealed upon completion of result analysis.
入排标准
- 年龄范围
- 22 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, aged 22-40 years.
- •BMI≥30 kg/m² (defined as obesity according to WHO standards).
- •Patients who are willing and able to provide informed consent and follow all study procedures, including ongoing visits to the Reproductive Center of the Third Affiliated Hospital of Zhengzhou University and undergoing relevant tests
- •Spouse aged 20-40 years, with menstrual regularity (menstrual cycle length of 21-35days, duration of 2-7days), with a BMI of 18.5≤BMI < 25 kg/m², planning for ART treatment at our center due to male factor infertility.
- •Not participating in any other research projects currently or in the preceding three months.
- •Willing to allow offspring conceived through the study to participate in follow-up research.
排除标准
- •Male reproductive urinary system abnormalities: active urinary reproductive system infections; hypogonadism; hyperprolactinemia; excessive estrogen; cryptorchidism, etc.;
- •Acute and chronic diseases that may affect fertility: chronic systemic diseases; history of systemic cytotoxic therapy or pelvic radiotherapy; other acute diseases that may affect study results;
- •Digestive system and metabolic abnormalities: acute and chronic digestive system diseases affecting digestive absorption function; history of or current eating disorders; allergies to ingredients in meal replacement products; gout, kidney stones, or gallstones; history of weight loss surgery;
- •Unhealthy lifestyle habits: meeting at least one of the following conditions: heavy alcohol consumption, daily smoking, history of drug abuse, history of substance abuse;
- •Personal factors affecting trial participation: impaired capacity to fully consent to participation in the study; major mental disorders; occupations requiring intense physical exercise; current diets that may interfere with the dietary plans of this study; exclusion of current or past use of hormones or anti-obesity drugs, or the use of other medications that affect hormone levels, carbohydrate metabolism, or appetite.
研究组 & 干预措施
Low-carbohydrate diet group
During the 12-week intervention, the first 8 weeks constitute the weight loss phase, where a low-carbohydrate diet, combined with meal replacement and daily dietary intake, is employed. Lifestyle guidance is provided on a one-to-one basis, accompanied by monitoring through a mobile platform. The subsequent 4 weeks involve the transition phase, during which personalized dietary and lifestyle adjustments are made
干预措施: Low-carbohydrate diet group (Dietary Supplement)
Health Education Group
12 weeks of one-on-one health promotion and mobile platform monitoring
干预措施: Health Education Group (Behavioral)
结局指标
主要结局
Weight
时间窗: Regular data collection between baseline and 12 weeks of weight loss intervention
kilogram (kg)
次要结局
- Visceral fat(Collected at baseline and until 12 weeks after weight loss intervention)
- Semen parameter- Sperm concentration(Collected at baseline and until 12 weeks after weight loss intervention)
- Semen parameter- Sperm progressive motility (PR)(Collected at baseline and until 12 weeks after weight loss intervention)
- Waist circumference(Regular data collection between baseline and 12 weeks of weight loss intervention)
- Semen parameter- Sperm morphology(Collected at baseline and until 12 weeks after weight loss intervention)
- Semen parameter- Sperm DNA fragmentation index (DFI)(Collected at baseline and until 12 weeks after weight loss intervention)
- Glucose metabolism-fasting glucose(Collected at baseline and until 12 weeks after weight loss intervention)
- Glucose metabolism-OGTT(Collected at baseline and until 12 weeks after weight loss intervention)
- Glucose metabolism-HbA1c(Collected at baseline and until 12 weeks after weight loss intervention)
- Semen parameter- Non-progressive motility (NP)(Collected at baseline and until 12 weeks after weight loss intervention)
- Heart rate(Regular data collection between baseline and 12 weeks of weight loss intervention)
- Glucose metabolism-C-peptide(Collected at baseline and until 12 weeks after weight loss intervention)
- Hip circumference(Regular data collection between baseline and 12 weeks of weight loss intervention)
- Lean mass(Collected at baseline and until 12 weeks after weight loss intervention)
- Semen parameter- Sperm motility(Collected at baseline and until 12 weeks after weight loss intervention)
- Semen parameter- Immotility (IM)(Collected at baseline and until 12 weeks after weight loss intervention)
- body mass index (BMI)(Regular data collection between baseline and 12 weeks of weight loss intervention)
- Fat mass(Collected at baseline and until 12 weeks after weight loss intervention)
- Abdominal fat(Collected at baseline and until 12 weeks after weight loss intervention)
- Blood pressure(Regular data collection between baseline and 12 weeks of weight loss intervention)
- Lipid profile-total cholesterol(Collected at baseline and until 12 weeks after weight loss intervention)
- Glucose metabolism-insulin(Collected at baseline and until 12 weeks after weight loss intervention)
- Sex hormones(Collected at baseline and until 12 weeks after weight loss intervention)
- Lipid profile-triglycerides(Collected at baseline and until 12 weeks after weight loss intervention)
- Lipid profile-LDL(Collected at baseline and until 12 weeks after weight loss intervention)
- Lipid profile-HDL(Collected at baseline and until 12 weeks after weight loss intervention)
- Lipid profile-VLDL(Collected at baseline and until 12 weeks after weight loss intervention)
研究者
Yichun Guan，PhD
Director, Reproductive Medicine Center,The Third Affiliated hospital of Zhengzhou University. Secretary-General, Asia Pacific Fertility Preservation Society
Third Affiliated Hospital of Zhengzhou University