Effects of a Low Valine Diet on Weight and Metabolism

Effect of Low Valine Diet on Body Weight and Metabolic Parameters

This study is testing if meal replacements with less valine can help overweight and obese people lose weight and improve their metabolism compared to regular meal replacements.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 16 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06883578 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are overweight or obese individuals aged 16 to 80 with a BMI of 24 kg/m² or higher.

Not a fit: Patients with significant liver diseases, poorly controlled diabetes, or other metabolic disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a novel dietary approach to effectively manage weight and improve metabolic health in overweight and obese patients.

How similar studies have performed: While dietary interventions for obesity are common, the specific focus on low-valine meal replacements is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Mingfeng Xia

Conditions Overweight/obesity; Metabolic Associated Fatty Liver Disease; Metabolic Diseases; Obesity; Dietary intervention; Low valine meal replacement