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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Health Education Group | Other | 12 weeks of one-on-one health promotion and mobile platform monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | kilogram (kg) | Regular data collection between baseline and 12 weeks of weight loss intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Semen parameter- Sperm concentration | Concentration (in million sperm cells/ml) | Collected at baseline and until 12 weeks after weight loss intervention |
| Semen parameter- Sperm motility | Sperm motility (%) |
| Measure | Description | Time Frame |
|---|---|---|
| Adult background | Demographic information and medical background | Collected prior baseline |
| Questionnaire - Adult physical activity | Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yichun Guan, PhD | Contact | +8613608695579 | lisamayguan@163.com | |
| JingYi Han | Contact | +8618789065980 | janethan0210@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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| 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. |
|
| Collected at baseline and until 12 weeks after weight loss intervention |
| Semen parameter- Sperm morphology | Morphology (%) | Collected at baseline and until 12 weeks after weight loss intervention |
| Semen parameter- Sperm DNA fragmentation index (DFI) | DFI (%) | Collected at baseline and until 12 weeks after weight loss intervention |
| Semen parameter- Sperm progressive motility (PR) | PR(%) | Collected at baseline and until 12 weeks after weight loss intervention |
| Semen parameter- Non-progressive motility (NP) | NP(%) | Collected at baseline and until 12 weeks after weight loss intervention |
| Semen parameter- Immotility (IM) | IM(%) | Collected at baseline and until 12 weeks after weight loss intervention |
| body mass index (BMI) | Calculated ad weight (kg)/height(m)^2 | Regular data collection between baseline and 12 weeks of weight loss intervention |
| Waist circumference | Centimetre(cm) | Regular data collection between baseline and 12 weeks of weight loss intervention |
| Hip circumference | Centimetre(cm) | Regular data collection between baseline and 12 weeks of weight loss intervention |
| Lean mass | (g), Assessed by an Anthropometric Analyzer | Collected at baseline and until 12 weeks after weight loss intervention |
| Fat mass | (g), Assessed by an Anthropometric Analyzer | Collected at baseline and until 12 weeks after weight loss intervention |
| Abdominal fat | (g), Assessed by an Anthropometric Analyzer | Collected at baseline and until 12 weeks after weight loss intervention |
| Visceral fat | (g), Assessed by an Anthropometric Analyzer | Collected at baseline and until 12 weeks after weight loss intervention |
| Blood pressure | mmHg | Regular data collection between baseline and 12 weeks of weight loss intervention |
| Heart rate | beats per minute | Regular data collection between baseline and 12 weeks of weight loss intervention |
| Lipid profile-triglycerides | Collected at baseline and until 12 weeks after weight loss intervention |
| Lipid profile-LDL | low-density lipoprotein | Collected at baseline and until 12 weeks after weight loss intervention |
| Lipid profile-HDL | high-density lipoprotein | Collected at baseline and until 12 weeks after weight loss intervention |
| Lipid profile-VLDL | very-low-density lipoprotein | Collected at baseline and until 12 weeks after weight loss intervention |
| Lipid profile-total cholesterol | 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 | Oral Glucose Tolerance Test | 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 | Samples will be analyzed for total testosterone, free testosterone, luteinizing hormone(LH), follicle-stimulating hormone(FSH), pituitary prolactin(PRL) and anti-müllerian hormone(AMH) | Collected at baseline and until 12 weeks after weight loss intervention |
| Collected at baseline and until 12 weeks after weight loss intervention |
| Questionnaire - Quality of life | Quality of life will be assessed by the validated tool, Short form-36 (SF-36). | Collected at baseline and until 12 weeks after weight loss intervention |
| Questionnaire - Psychological condition | Psychological condition will be assessed by the validated tool, Depression-Anxiety-Stress Scale (DASS-21) | Collected at baseline and until 12 weeks after weight loss intervention |
| Questionnaire - Sleep | Sleep will be assessed by the validated tool, Pittsburgh sleep quality index questionnaire (PSQI). | Collected at baseline and until 12 weeks after weight loss intervention |
| Spouse's reproductive outcome - Methods of Fertilization | The information will be collected through follow-up telephone calls or clinic registration. In the case of non-natural conception, specific assisted reproductive methods should be recorded in the registration | through study completion, an average of 6 months |
| Spouse's reproductive outcome - Time to pregnancy | Duration of time to conception defined from time point allowed to conceive to registration of pregnancy. | through study completion, an average of 6 months |
| Spouse's reproductive outcome - Length of gestational age | gestational weeks | Assessed at birth of offspring |
| Spouse's reproductive outcome - Medication use | Medication use during labor | Collected from initiation of labor until completed birth of offspring |
| Spouse's reproductive outcome - Delivery mode | Delivery mode (rupture of membranes or premature contractions, vaginal, cesarean section, instrumental delivery, miscarriage and stillbirth) | Collected at birth of offspring |
| Spouse's reproductive outcome - Pregnancy complications | Pregnancy complications e.g. miscarriage, abortion (induced and indication for abortion), hydramnios, gestational hypertension, preeclampsia, need for maternal corticosteroid treatment for fetal lung maturation, urinary tract infection). | through study completion, an average of 18 months |
| Spouse's reproductive outcome - Obstetrics complications | Obstetrics complications (e.g. preterm prelabour rupture of the membranes, shoulder dystocia, birth trauma (perinatal rupture), postpartum hemorrhage, maternal infections, maternal hospitalization) | Collected at birth of offspring |
| Fetal and offspring - Apgar score | Apgar score (0-10). The higher the score, the better health condition of the offspring | Collected at birth of offspring |
| Fetal and offspring - body weight | Fetal body weight will be measured with ultrasound during pregnancy and offspring body weight will be measured using an electronic scale. | through study completion, an average of 18 months |
| Fetal and offspring - Birth defects/abnormalities | Collected at birth of offspring |
| Fetal and offspring - Cognitive development of offspring | Offspring cognitive development will be assessed by a Habituation and Free Play Test. | Collected at 6, 12 and 18 months after birth. |
| Labs - Semen epigenetics marks | Epigenetic profile based on array-measurements. Analysed for methylation changes. | Collected at baseline and until 12 weeks after weight loss intervention |
| Labs - Adult Epigenetics | Epigenetics analyses from whole blood. Will be analysed for methylation changes. The indicators for epigenetic testing include DNA methylation levels, histone modifications, non-coding RNA expression, etc. | Collected at baseline and until 12 weeks after weight loss intervention |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |