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

NCT06339840 | Recruiting DMC

• 1 other identifier: 2024-036-02
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Weight

  kilogram (kg)

  Regular data collection between baseline and 12 weeks of weight loss intervention

Secondary Outcomes (25)

• Semen parameter- Sperm concentration

  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- 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

• Semen parameter- Sperm progressive motility (PR)

  Collected at baseline and until 12 weeks after weight loss intervention

Other Outcomes (18)

• Adult background

  Collected prior baseline

• Questionnaire - Adult physical activity

  Collected at baseline and until 12 weeks after weight loss intervention

• Questionnaire - Quality of life

  Collected at baseline and until 12 weeks after weight loss intervention

Study Arms (2)

Low-carbohydrate diet group

EXPERIMENTAL

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

Dietary Supplement: Low-carbohydrate diet group

Health Education Group

OTHER

12 weeks of one-on-one health promotion and mobile platform monitoring

Behavioral: Health Education Group

Interventions

Low-carbohydrate diet group DIETARY_SUPPLEMENT

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.

Also known as: Intensive Intervention Group

Low-carbohydrate diet group

Health Education Group BEHAVIORAL

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.

Health Education Group

Eligibility Criteria

• Age: 22 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \&lt; 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Third Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Central Study Contacts

Yichun Guan, PhD

CONTACT

+8613608695579; lisamayguan@163.com

JingYi Han

CONTACT

+8618789065980; janethan0210@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Reproductive Medicine Center,The Third Affiliated hospital of Zhengzhou University. Secretary-General, Asia Pacific Fertility Preservation Society

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 1, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2025-10

Locations

CN (1)