Effect of Low Valine Diet on Body Weight and Metabolic Parameters
Recruiting · NCT06883578 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Zhongshan Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Long-term intermittent low valine meal replacementLong-term intermittent normal meal replacementShort-term continuous low-valine meal replacementsShort-term continuous normal meal replacement
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.
Who can take part
Age range
16 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Zhongshan Hospital, Fudan University - Shanghai, Shanghai Municipality, China