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

Обзор

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.

Вмешательства

• Пищевая добавка 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. Nutr
• Поведенческое 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 lifestyl

Первичные конечные точки

• Weight [Срок оценки: Regular data collection between baseline and 12 weeks of weight loss intervention]

Вторичные конечные точки (12)

• Semen parameter- Sperm concentration [Срок оценки: Collected at baseline and until 12 weeks after weight loss intervention]
• Semen parameter- Sperm motility [Срок оценки: Collected at baseline and until 12 weeks after weight loss intervention]
• Semen parameter- Sperm morphology [Срок оценки: Collected at baseline and until 12 weeks after weight loss intervention]
• Semen parameter- Sperm DNA fragmentation index (DFI) [Срок оценки: Collected at baseline and until 12 weeks after weight loss intervention]
• Semen parameter- Sperm progressive motility (PR) [Срок оценки: Collected at baseline and until 12 weeks after weight loss intervention]
• Semen parameter- Non-progressive motility (NP) [Срок оценки: Collected at baseline and until 12 weeks after weight loss intervention]
• Semen parameter- Immotility (IM) [Срок оценки: Collected at baseline and until 12 weeks after weight loss intervention]
• body mass index (BMI) [Срок оценки: Regular data collection between baseline and 12 weeks of weight loss intervention]
• Waist circumference [Срок оценки: Regular data collection between baseline and 12 weeks of weight loss intervention]
• Hip circumference [Срок оценки: Regular data collection between baseline and 12 weeks of weight loss intervention]
• Lean mass [Срок оценки: Collected at baseline and until 12 weeks after weight loss intervention]
• Fat mass [Срок оценки: Collected at baseline and until 12 weeks after weight loss intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Third Affiliated Hospital of Zhengzhou University — Чжэнчжоу

Идентификаторы

NCT: NCT06339840 · 2024-036-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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