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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-term continuous normal meal replacement intervention group | Placebo Comparator | 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 replacement intervention group | Experimental | 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 intervention group | Placebo Comparator | 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 intervention group | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fat mass | From enrollment to the end of intervention at 2 weeks or 16 weeks | |
| Lean mass | From enrollment to the end of intervention at 2 weeks or 16 weeks | |
| Fasting plasma glucose |
| Measure | Description | Time Frame |
|---|---|---|
| Serum proteomic profiles | From enrollment to the end of intervention at 2 weeks or 16 weeks | |
| Serum metabolomic profiles | From enrollment to the end of intervention at 2 weeks or 16 weeks | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingfeng Xia | Contact | +86 136 1182 6871 | xia.mingfeng@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Eligible subjects were enrolled according to the inclusion criteria. They will be enrolled into short-term continuous intervention or long-term intermittent intervention program according to their wishes, until the subjects of the intervention program are full.The subjects of the short-term 2-week continuous intervention or long-term 16-week intermittent intervention studies will be randomly assigned into the control meal replacement group and the low valine meal replacement group by random allocation separately, with 12 people in each group.
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| 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. |
|
| From enrollment to the end of intervention at 2 weeks or 16 weeks |
| 2h postload plasma glucose | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| Fasting insulin | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| 2h postload insulin | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| Triglycerides | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| Cholesterol | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| LDL cholesterol | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| HDL cholesterol | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| Total bilirubin | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| Conjugated bilirubin | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| Creatinine | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| Uric acid | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| Systolic blood pressure | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| Diastolic blood pressure | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| Waist circumference | From enrollment to the end of intervention at 2 weeks or 16 weeks |
| HbA1c | Measured only in long-term intermittent intervention subjects | 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 | From enrollment to the end of intervention at 16 weeks |
| Serum lipidomic profiles |
| From enrollment to the end of intervention at 2 weeks or 16 weeks |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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