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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

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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