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NCT Number: NCT06339840

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

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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Key information

Conditions

Obesity Artificial Insemination Body Weight Body Weight Changes IVF-ET Male Fertility Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

22 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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.

Exclusion criteria

  • 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;
  • Personal factors affecting trial participation: impaired capacity to fully consent to participation in the study; major mental disorders; occupations requiring intense physical exercise; current diets that may interfere with the dietary plans of this study; exclusion of current or past use of hormones or anti-obesity drugs, or the use of other medications that affect hormone levels, carbohydrate metabolism, or appetite.

Treatment and study plan

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.

Other names: Intensive Intervention 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.

Primary outcomes

  1. Weight

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

    kilogram (kg)

Secondary outcomes

  1. Semen parameter- Sperm concentration

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    Concentration (in million sperm cells/ml)

  2. Semen parameter- Sperm motility

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    Sperm motility (%)

  3. Semen parameter- Sperm morphology

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    Morphology (%)

  4. Semen parameter- Sperm DNA fragmentation index (DFI)

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    DFI (%)

  5. Semen parameter- Sperm progressive motility (PR)

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    PR(%)

  6. Semen parameter- Non-progressive motility (NP)

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    NP(%)

  7. Semen parameter- Immotility (IM)

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    IM(%)

  8. body mass index (BMI)

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

    Calculated ad weight (kg)/height(m)^2

  9. Waist circumference

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

    Centimetre(cm)

  10. Hip circumference

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

    Centimetre(cm)

  11. Lean mass

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    (g), Assessed by an Anthropometric Analyzer

  12. Fat mass

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    (g), Assessed by an Anthropometric Analyzer

  13. Abdominal fat

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    (g), Assessed by an Anthropometric Analyzer

  14. Visceral fat

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    (g), Assessed by an Anthropometric Analyzer

  15. Blood pressure

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

    mmHg

  16. Heart rate

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

    beats per minute

  17. Lipid profile-triglycerides

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

  18. Lipid profile-LDL

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    low-density lipoprotein

  19. Lipid profile-HDL

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    high-density lipoprotein

  20. Lipid profile-VLDL

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    very-low-density lipoprotein

  21. Lipid profile-total cholesterol

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

  22. Glucose metabolism-fasting glucose

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

  23. Glucose metabolism-OGTT

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    Oral Glucose Tolerance Test

  24. Glucose metabolism-insulin

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

  25. Sex hormones

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    Samples will be analyzed for total testosterone, free testosterone, luteinizing hormone(LH), follicle-stimulating hormone(FSH), pituitary prolactin(PRL) and anti-müllerian hormone(AMH)

Other outcomes

  1. Adult background

    Time frame: Collected prior baseline

    Demographic information and medical background

  2. Questionnaire - Adult physical activity

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ)

  3. Questionnaire - Quality of life

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    Quality of life will be assessed by the validated tool, Short form-36 (SF-36).

  4. Questionnaire - Psychological condition

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    Psychological condition will be assessed by the validated tool, Depression-Anxiety-Stress Scale (DASS-21)

  5. Questionnaire - Sleep

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    Sleep will be assessed by the validated tool, Pittsburgh sleep quality index questionnaire (PSQI).

  6. Spouse's reproductive outcome - Methods of Fertilization

    Time frame: through study completion, an average of 6 months

    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

  7. Spouse's reproductive outcome - Time to pregnancy

    Time frame: through study completion, an average of 6 months

    Duration of time to conception defined from time point allowed to conceive to registration of pregnancy.

  8. Spouse's reproductive outcome - Length of gestational age

    Time frame: Assessed at birth of offspring

    gestational weeks

  9. Spouse's reproductive outcome - Medication use

    Time frame: Collected from initiation of labor until completed birth of offspring

    Medication use during labor

  10. Spouse's reproductive outcome - Delivery mode

    Time frame: Collected at birth of offspring

    Delivery mode (rupture of membranes or premature contractions, vaginal, cesarean section, instrumental delivery, miscarriage and stillbirth)

  11. Spouse's reproductive outcome - Pregnancy complications

    Time frame: through study completion, an average of 18 months

    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).

  12. Spouse's reproductive outcome - Obstetrics complications

    Time frame: Collected at birth of offspring

    Obstetrics complications (e.g. preterm prelabour rupture of the membranes, shoulder dystocia, birth trauma (perinatal rupture), postpartum hemorrhage, maternal infections, maternal hospitalization)

  13. Fetal and offspring - Apgar score

    Time frame: Collected at birth of offspring

    Apgar score (0-10). The higher the score, the better health condition of the offspring

  14. Fetal and offspring - body weight

    Time frame: through study completion, an average of 18 months

    Fetal body weight will be measured with ultrasound during pregnancy and offspring body weight will be measured using an electronic scale.

  15. Fetal and offspring - Birth defects/abnormalities

    Time frame: Collected at birth of offspring

  16. Fetal and offspring - Cognitive development of offspring

    Time frame: Collected at 6, 12 and 18 months after birth.

    Offspring cognitive development will be assessed by a Habituation and Free Play Test.

  17. Labs - Semen epigenetics marks

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    Epigenetic profile based on array-measurements. Analysed for methylation changes.

  18. Labs - Adult Epigenetics

    Time frame: Collected at baseline and until 12 weeks after weight loss intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

JingYi Han

CONTACT

[email protected]

+8618789065980

Yichun Guan, PhD

CONTACT

[email protected]

+8613608695579

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital of Zhengzhou University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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