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Clinical Trials in China / NCT06883578
Recruiting Not applicable

Effect of Low Valine Diet on Body Weight and Metabolic Parameters

NCT06883578 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Not applicable
Started
2025-02-18
Last updated
2025-03-19

Condition(s) studied

Overweight/obesityMetabolic Associated Fatty Liver DiseaseMetabolic Diseases

Investigational drug(s) / intervention(s)

Short-term continuous normal meal replacementShort-term continuous low-valine meal replacementsLong-term intermittent normal meal replacementLong-term intermittent low valine meal replacement

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.

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.

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.

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.

Study summary

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

Sex
ALL
Min age
16 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Body weight — From enrollment to the end of intervention at 2 weeks or 16 weeks

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06883578 on ClinicalTrials.gov ↗ ← All trials in China