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NCT06883578Recruiting

Effect of Low Valine Diet on Body Weight and Metabolic Parameters

Source: ClinicalTrials.gov · Last updated 19 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
48 (estimated)
First submitted
9 Mar 2025
Start date
18 Feb 2025
Primary completion date
30 Apr 2026
Lead sponsor
Shanghai Zhongshan Hospital
NCT number
NCT06883578

What you commit to

  • Study type: Interventional
  • Planned participants: 48
  • From 18 Feb 2025 to the primary completion date, 30 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Continuously used drugs that may cause weight changes for more than 2 weeks in the past year (such as glucocorticoids, thyroid hormones, etc.);
  • Those who had gastric volume reduction surgery or digestive tract surgery;

Other illness

  • 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.;
  • Life expectancy of no more than 3 years in the presence of serious health conditions;
  • Those who cannot participate in the follow-up of the intervention due to other conditions;
  • Those diagnosed with any tumor disease;

Lab values

  • 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;

Other

  • Excessive drinkers (defined as: in the past 6 months, the weekly alcohol intake of men exceeds 140g, and that of women exceeds 70g);
  • Those who plan to get pregnant in the near future;
  • Participated in other clinical trials in the past 4 weeks;
  • Subjects who participated in strenuous exercise or planned to change their diet structure;
  • Unable to sign the informed consent form.

Who the study is looking for

  • Male or female, 16 years old ≤ age ≤ 80 years old;
  • BMI ≥ 24kg/m2

Age in the registry: 16 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhongshan Hospital,Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.