Effect of Low Valine Diet on Body Weight and Metabolic Parameters
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-80
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Male or female, 16 years old ≤ age ≤ 80 years old;
BMI ≥ 24kg/m2
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Short-term continuous normal meal replacement
- Short-term continuous low-valine meal replacements
- Long-term intermittent normal meal replacement
- Long-term intermittent low valine meal replacement
Treatment groups
48 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov