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Search / Trial NCT06883578

Effect of Low Valine Diet on Body Weight and Metabolic Parameters

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Mar 15, 2025

Trial Information

Current as of April 29, 2025

Recruiting

Keywords

Obesity Dietary Intervention Low Valine Meal Replacement

ClinConnect Summary

This clinical trial is studying how a low-valine diet affects body weight and metabolic health in people who are overweight or have metabolic-related conditions, like fatty liver disease. The researchers want to find out if using ordinary meal replacements or specially designed low-valine meal replacements can help participants lose weight and reduce their risk of health issues linked to being overweight.

To join the study, participants need to be between 16 and 80 years old and have a body mass index (BMI) of 24 or higher. However, there are some exclusions, such as those with certain liver diseases, severe kidney problems, or diabetes that isn't well controlled. If eligible, participants will receive either the regular or low-valine meal replacements and will be monitored throughout the study. This trial is currently recruiting participants, and it's a great opportunity for those looking to improve their health through diet.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Male or female, 16 years old ≤ age ≤ 80 years old;
  • BMI ≥ 24kg/m2
  • Exclusion Criteria:
  • Excessive drinkers (defined as: in the past 6 months, the weekly alcohol intake of men exceeds 140g, and that of women exceeds 70g);
  • Liver diseases caused by other reasons: such as alcoholic liver disease, acute and chronic viral hepatitis, drug-induced, immune hepatitis (AMA, SMA, ANA), cirrhosis, liver cancer, etc.;
  • Other diseases that affect glucose and lipid metabolism: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.;
  • Poorly controlled diabetic patients: HbA1c \>9.5% within three months; or use of hypoglycemic drugs that may affect weight, including pioglitazone, GLP-1, SGLT2 inhibitors;
  • Chronic kidney disease or severe renal impairment, defined as serum creatinine greater than 2.0mg/dL;
  • Serum ALT greater than 3 times the upper limit of normal;
  • Life expectancy of no more than 3 years in the presence of serious health conditions;
  • Those who plan to get pregnant in the near future;
  • Those who cannot participate in the follow-up of the intervention due to other conditions;
  • Continuously used drugs that may cause weight changes for more than 2 weeks in the past year (such as glucocorticoids, thyroid hormones, etc.);
  • Participated in other clinical trials in the past 4 weeks;
  • Those who had gastric volume reduction surgery or digestive tract surgery;
  • Those diagnosed with any tumor disease;
  • Subjects who participated in strenuous exercise or planned to change their diet structure;
  • Unable to sign the informed consent form.

About Shanghai Zhongshan Hospital

Shanghai Zhongshan Hospital is a prestigious medical institution affiliated with Fudan University, renowned for its commitment to advancing healthcare through rigorous clinical research and innovative patient care. With a focus on multidisciplinary collaboration and cutting-edge medical technologies, the hospital conducts a wide range of clinical trials aimed at improving treatment outcomes across various specialties. Its state-of-the-art facilities and highly qualified research team ensure that trials adhere to the highest ethical and scientific standards, contributing significantly to the global body of medical knowledge and enhancing patient health outcomes.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported