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Effect of Low Valine Diet on Body Weight and Metabolic Parameters
RECRUITINGN/ASponsored by Shanghai Zhongshan Hospital
Actively Recruiting
PhaseN/A
SponsorShanghai Zhongshan Hospital
Started2025-02-18
Est. completion2026-04-30
Eligibility
Age16 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06883578
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 randomized double-blind controlled clinical trial.
Eligibility
Age: 16 Years – 80 YearsHealthy volunteers accepted
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.
Conditions4
Liver DiseaseMetabolic Associated Fatty Liver DiseaseMetabolic DiseasesOverweight/Obesity
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Actively Recruiting
PhaseN/A
SponsorShanghai Zhongshan Hospital
Started2025-02-18
Est. completion2026-04-30
Eligibility
Age16 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06883578