Effects of a Low Valine Diet on Weight and Metabolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of low-valine meal replacements on weight loss and metabolic health in overweight and obese individuals. It employs a randomized, double-blind, controlled design, comparing short-term and long-term interventions of low-valine meal replacements against standard meal replacements. Participants will be enrolled based on specific inclusion and exclusion criteria and will be randomly assigned to one of the intervention groups. The study aims to provide insights into dietary interventions for managing obesity and related metabolic diseases.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Mingfeng Xia
• Email: xia.mingfeng@zs-hospital.sh.cn
• Phone: +86 136 1182 6871

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.