The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 22
Maximum Age: 40
Healthy Volunteers: f
View:

• 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 AIH or IVF 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.

Locations
Other Locations
China
Third Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Yichun Guan, PhD
lisamayguan@163.com
+8613608695579
Backup
JingYi Han
janethan0210@qq.com
+8618789065980
Time Frame
Start Date: 2024-06-20
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 66
Treatments
Experimental: 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
Other: Health Education Group
12 weeks of one-on-one health promotion and mobile platform monitoring
Related Therapeutic Areas
Sponsors
Leads: Third Affiliated Hospital of Zhengzhou University

This content was sourced from clinicaltrials.gov

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