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.
This study is a randomized, double-blind, controlled clinical study, which aims to explore the advantages of low valine meal replacements in weight loss and improving metabolism compared with ordinary meal replacements. It is divided into two parts: 1) short-term continuous low valine meal replacement intervention (2 weeks) and 2) long-term intermittent low valine meal replacement intervention (16 weeks). Overweight and obese subjects will be enrolled according to the inclusion and exclusion criteria, and entered the short-term continuous intervention and long-term intermittent intervention projects according to the subjects' wishes until the number of subjects planned for the project is filled. The subjects of the short-term 2-week continuous intervention and long-term 16-week intermittent intervention studies will be randomly assigned to the control meal replacement group and the low valine meal replacement group by random allocation, with 12 people in each group. The randomization sequence of this study will be generated by an independent statistician team based on the clinical research plan and random allocation parameter configuration file. During the generation process, all necessary information and related parameters, including system software version, random number seed, sequence length, block length, group information, inter-group ratio, stratification factors and levels, will be recorded in detail in the randomization table to ensure the reproducibility and reliability of randomization. All subjects and investigators (including members of the research team and the intervention implementers) are blind to the grouping of subjects during the study period. The primary outcome is the change of body weight, which will be measured at baseline and at the end of follow-up. Secondary endpoints include changes in plasma glucose, serum lipid profiles, liver enzymes, and DXA body composition. For patients with long-term low-valine meal replacement intervention, liver fat content measured by PDFF will also be measured. At the same time, serum proteomic, metabolomic and lipidomic profiles of all subjects at the end of follow-up will be analyzed to preliminarily expand the study of the possible mechanism of low valine diet in regulating body weight.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
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.
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.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGBody weight
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
Fat mass
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
Lean mass
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
Fasting plasma glucose
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
2h postload plasma glucose
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
Fasting insulin
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
2h postload insulin
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
Triglycerides
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
Cholesterol
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
LDL cholesterol
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
HDL cholesterol
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
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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.
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.
Total bilirubin
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
Conjugated bilirubin
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
Creatinine
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
Uric acid
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
Systolic blood pressure
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
Diastolic blood pressure
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
Waist circumference
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
HbA1c
Measured only in long-term intermittent intervention subjects
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
PDFF liver fat content
Measured only in long-term intermittent intervention subjects
Time frame: From enrollment to the end of intervention at 16 weeks