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

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.

Conditions

• Obesity
• Weight Loss
• Male Fertility
• Artificial Insemination
• IVF-ET

Interventions

DIETARY_SUPPLEMENT

Low-carbohydrate diet group

During the initial 8-week weight loss phase, participants will adopt a low-carbohydrate dietary pattern (with carbohydrate energy ratio of 20-30%, protein energy ratio of 30-40%, and fat energy ratio of 40-45%), with a caloric intake approximately 75% of their usual daily intake, but not less than 1200 kcal. Throughout the intervention period, participants will receive a daily nutritionally balanced meal replacement for 8 weeks to substitute for staple foods and control carbohydrate intake. Nutritionists will reinforce interventions by setting health goals, providing health education, implementing dietary and exercise interventions, and monitoring through a combined approach using a mobile platform. During the subsequent 4-week transition phase, participants' diets will gradually transition to a balanced dietary pattern (with carbohydrate energy ratio of 45-60%, protein energy ratio of 20-30%, and fat energy ratio of 20-25%) under the guidance of nutritionists.

BEHAVIORAL

Health Education Group

Upon enrollment, nutritionists will provide lifestyle guidance to patients, including personalized adjustments such as limiting total energy intake to \<1600 kcal/day, adjusting macronutrient distribution to 45-55% for carbohydrates, 20-30% for fats, and 20-30% for protein. Participants are advised to accumulate at least 150 minutes of moderate-intensity aerobic exercise per week (achieving 50%-70% of maximum heart rate). At enrollment, nutritionists will educate participants on healthy lifestyle principles, train them on nutritional intervention tools, and assist in food selection for weight management planning. Throughout the intervention, nutritionists will conduct follow-ups with patients via phone or mobile platforms to monitor weekly dietary and exercise habits, weight changes, and address any participant concerns promptly.

Sponsors & Collaborators

• Third Affiliated Hospital of Zhengzhou University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Max Age

40 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-20

Primary Completion

2027-06-30

Completion

2027-12-31

Countries

• China

Study Locations