Actively Recruiting

Phase Not Applicable
Age: 16Years - 80Years
All Genders
NCT06883578

Effect of Low Valine Diet on Body Weight and Metabolic Parameters

Led by Shanghai Zhongshan Hospital · Updated on 2025-03-19

48

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect of Low Valine Diet on Body Weight and Metabolic Parameters

Who Can Participate

Age: 16Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, 16 years old 64 age 64 80 years old
  • Body mass index (BMI) of 24 kg/m2 or higher
Not Eligible

You will not qualify if you...

  • Excessive alcohol intake: men over 140g/week, women over 70g/week in past 6 months
  • Liver diseases from other causes such as alcoholic liver disease, viral hepatitis, drug-induced liver injury, immune hepatitis, cirrhosis, or liver cancer
  • Other diseases affecting glucose and lipid metabolism like hyperthyroidism, hypothyroidism, or Cushing's syndrome
  • Poorly controlled diabetes with HbA1c >9.5% in past 3 months or use of weight-affecting hypoglycemic drugs
  • Chronic kidney disease or severe renal impairment with serum creatinine >2.0 mg/dL
  • Serum ALT levels greater than three times the upper limit of normal
  • Serious health conditions with life expectancy less than 3 years
  • Planning pregnancy in the near future
  • Unable to participate in follow-up due to other conditions
  • Continuous use of weight-affecting drugs for more than 2 weeks in past year
  • Participation in other clinical trials within past 4 weeks
  • History of gastric volume reduction or digestive tract surgery
  • Diagnosis of any tumor disease
  • Participation in strenuous exercise or planned diet changes
  • Unable to sign informed consent form

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200031

Actively Recruiting

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Research Team

M

Mingfeng Xia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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