Clinical trial

Effect of Low Valine Diet on Body Weight and Metabolic Parameters

Recruiting now · Not applicable · 1 countries · Registry ID NCT06883578

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age16 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionOverweight/obesity, Metabolic Associated Fatty Liver Disease, Metabolic Diseases

Full registry 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.

Treatments and study arms

Short-term continuous normal meal replacement

Dietary Supplement

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.

Short-term continuous low-valine meal replacements

Dietary Supplement

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.

Long-term intermittent normal meal replacement

Dietary Supplement

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.

Long-term intermittent low valine meal replacement

Dietary Supplement

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.

Primary outcomes

Body weightFrom enrollment to the end of intervention at 2 weeks or 16 weeks

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Zhongshan Hospital, Fudan University🇨🇳 Shanghai, Shanghai Municipality, China

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Mingfeng XiaContact

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