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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.