Status:
RECRUITING
Effect of Low Valine Diet on Body Weight and Metabolic Parameters
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Overweight/obesity
Metabolic Associated Fatty Liver Disease
Eligibility:
All Genders
16-80 years
Phase:
NA
Brief Summary
This study aimed to explore the effects of ordinary meal replacements and low-valine meal replacements on the weight and risk of related metabolic diseases in overweight/obese patients through a rando...
Detailed Description
This study is a randomized, double-blind, controlled clinical study, which aims to explore the advantages of low valine meal replacements in weight loss and improving metabolism compared with ordinary...
Eligibility Criteria
Inclusion
- Male or female, 16 years old ≤ age ≤ 80 years old;
- BMI ≥ 24kg/m2
Exclusion
- 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.
Key Trial Info
Start Date :
February 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06883578
Start Date
February 18 2025
End Date
April 30 2026
Last Update
March 19 2025
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200031