ObesityNCT06339840
The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males
A study testing Low-carbohydrate diet group and Health Education Group in people with Obesity and Weight Loss, run by Third Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 40 years, men only
- Conditions the study is for
- Obesity, Weight Loss, Male Fertility
- What is being tested?
- Low-carbohydrate diet group and Health Education Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yichun Guan, PhD, 13608695579, lisamayguan@163.com
Jingyi Han, MD, 13607695810, janethan0210@qq.com
About this study
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.
Read more
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
- Being tested
- Low-carbohydrate diet group, Health Education Group
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-carbohydrate diet groupDietary supplement
Also called Intensive Intervention 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.
Health Education GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Low-carbohydrate diet group |
| Health Education Group | Other | 12 weeks of one-on-one health promotion and mobile platform monitoring Receives: Behavioral: Health Education Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
kilogram (kg)
Measured: Regular data collection between baseline and 12 weeks of weight loss intervention
Secondary outcomes (25)
Semen parameter- Sperm concentration
Concentration (in million sperm cells/ml)
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Semen parameter- Sperm motility
Sperm motility (%)
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Semen parameter- Sperm morphology
Morphology (%)
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Semen parameter- Sperm DNA fragmentation index (DFI)
DFI (%)
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Semen parameter- Sperm progressive motility (PR)
PR(%)
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Semen parameter- Non-progressive motility (NP)
NP(%)
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Semen parameter- Immotility (IM)
IM(%)
Measured: Collected at baseline and until 12 weeks after weight loss intervention
body mass index (BMI)
Calculated ad weight (kg)/height(m)^2
Measured: Regular data collection between baseline and 12 weeks of weight loss intervention
Waist circumference
Centimetre(cm)
Measured: Regular data collection between baseline and 12 weeks of weight loss intervention
Hip circumference
Centimetre(cm)
Measured: Regular data collection between baseline and 12 weeks of weight loss intervention
Lean mass
(g), Assessed by an Anthropometric Analyzer
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Fat mass
(g), Assessed by an Anthropometric Analyzer
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Abdominal fat
(g), Assessed by an Anthropometric Analyzer
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Visceral fat
(g), Assessed by an Anthropometric Analyzer
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Blood pressure
mmHg
Measured: Regular data collection between baseline and 12 weeks of weight loss intervention
Heart rate
beats per minute
Measured: Regular data collection between baseline and 12 weeks of weight loss intervention
Lipid profile-triglycerides
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Lipid profile-LDL
low-density lipoprotein
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Lipid profile-HDL
high-density lipoprotein
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Lipid profile-VLDL
very-low-density lipoprotein
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Lipid profile-total cholesterol
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Glucose metabolism-fasting glucose
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Glucose metabolism-OGTT
Oral Glucose Tolerance Test
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Glucose metabolism-insulin
Measured: 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)
Measured: Collected at baseline and until 12 weeks after weight loss intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start20 Jun 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yichun Guan，PhD, Third Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339840
- Sponsor's protocol ID
- 2024-036-02
- Status last verified
- Oct 2025
- First submitted
- 14 Mar 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males
- ClinicalTrials.gov ID
- NCT06339840
- Acronym / sponsor ID
- 2024-036-02
- Conditions
- Obesity, Weight Loss, Male Fertility, Artificial Insemination, IVF-ET
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-carbohydrate diet group | Experimental | Dietary Supplement: Low-carbohydrate diet groupDuring 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 | Behavioral: Health Education Group12 weeks of one-on-one health promotion and mobile platform monitoring |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-carbohydrate diet groupAlso: Intensive Intervention GroupDuring 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. | Dietary supplement | Low-carbohydrate diet group |
| Health Education GroupUpon 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. | Behavioural | Health Education Group |
Primary outcome
Weight
Time frame: Regular data collection between baseline and 12 weeks of weight loss intervention
kilogram (kg)
25 secondary outcomes
Semen parameter- Sperm concentration
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Semen parameter- Sperm motility
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Semen parameter- Sperm morphology
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Semen parameter- Sperm DNA fragmentation index (DFI)
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Semen parameter- Sperm progressive motility (PR)
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Semen parameter- Non-progressive motility (NP)
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Semen parameter- Immotility (IM)
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
body mass index (BMI)
Time frame: Regular data collection between baseline and 12 weeks of weight loss intervention
Waist circumference
Time frame: Regular data collection between baseline and 12 weeks of weight loss intervention
Hip circumference
Time frame: Regular data collection between baseline and 12 weeks of weight loss intervention
Lean mass
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Fat mass
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Abdominal fat
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Visceral fat
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Blood pressure
Time frame: Regular data collection between baseline and 12 weeks of weight loss intervention
Heart rate
Time frame: Regular data collection between baseline and 12 weeks of weight loss intervention
Lipid profile-triglycerides
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Lipid profile-LDL
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Lipid profile-HDL
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Lipid profile-VLDL
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Lipid profile-total cholesterol
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Glucose metabolism-fasting glucose
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Glucose metabolism-OGTT
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Glucose metabolism-insulin
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Sex hormones
Time frame: Collected at baseline and until 12 weeks after weight loss intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-carbohydrate diet group and Health Education Group in people with Obesity and Weight Loss, run by Third Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yichun Guan, PhD (+8613608695579, lisamayguan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Regular data collection between baseline and 12 weeks of weight loss intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.