RECRUITINGINTERVENTIONAL

Effect of Low Valine Diet on Body Weight and Metabolic Parameters

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female, 16 years old ≤ age ≤ 80 years old; - BMI ≥ 24kg/m2 Who Should NOT Join This Trial: - 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 willing to sign a consent form form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DIETARY_SUPPLEMENT

Short-term continuous normal meal replacement

The normal meal replacement intake is calculated at 25kcal/kg body weight per person per day, with the calorie ratio for breakfast, lunch and dinner being 1:2:2. A meal replacement diet is given for 2 consecutive weeks.

DIETARY_SUPPLEMENT

Short-term continuous low-valine meal replacements

The low valine meal replacement intake is calculated at 25kcal/kg body weight per person per day, with the calorie ratio for breakfast, lunch and dinner being 1:2:2. A meal replacement diet is given for 2 consecutive weeks.

DIETARY_SUPPLEMENT

Long-term intermittent normal meal replacement

The normal meal replacement intake was calculated at 25 kcal/kg body weight per person per day, with the calorie distribution ratio of 1:2:2 for breakfast, lunch and dinner. A meal replacement diet was used for 2 consecutive days per week for 16 consecutive weeks.

DIETARY_SUPPLEMENT

Long-term intermittent low valine meal replacement

The low valine meal replacement intake was calculated at 25 kcal/kg body weight per person per day, with the calorie distribution ratio of 1:2:2 for breakfast, lunch and dinner. A meal replacement diet was used for 2 consecutive days per week for 16 consecutive weeks.

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China