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

NARecruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

June 20, 2024

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2027

Conditions
ObesityWeight LossMale FertilityArtificial InseminationIVF-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.

Trial Locations (1)

450052

RECRUITING

Third Affiliated Hospital of Zhengzhou University, Zhengzhou

All Listed Sponsors
lead

Third Affiliated Hospital of Zhengzhou University

OTHER