Overweight/obesityNCT06883578
Effect of Low Valine Diet on Body Weight and Metabolic Parameters
A study testing Short-term continuous normal meal replacement, Short-term continuous low-valine meal replacements and Long-term intermittent normal meal replacement in people with Overweight/obesity and Metabolic Associated Fatty Liver Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Overweight/obesity, Metabolic Associated Fatty Liver Disease, Metabolic Diseases
- What is being tested?
- Short-term continuous normal meal replacement, Short-term continuous low-valine meal replacements and Long-term intermittent normal meal replacement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female, 16 years old ≤ age ≤ 80 years old;
- BMI ≥ 24kg/m2
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
Mingfeng Xia, +86 136 1182 6871, xia.mingfeng@zs-hospital.sh.cn
About this study
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.
Read the detailed description
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.
- Being tested
- Short-term continuous normal meal replacement, Short-term continuous low-valine meal replacements, Long-term intermittent normal meal replacement, Long-term intermittent low valine meal replacement
- Keywords
- Obesity, Dietary intervention, Low valine meal replacement
- Medical subject headings
- Overweight, Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-term continuous normal meal replacementDietary 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 replacementsDietary 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 replacementDietary 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 replacementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Short-term continuous normal meal replacement |
| 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. Receives: Dietary Supplement: Short-term continuous low-valine meal replacements |
| 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. Receives: Dietary Supplement: Long-term intermittent normal meal replacement |
| 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. Receives: Dietary Supplement: Long-term intermittent low valine meal replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
Secondary outcomes (19)
Fat mass
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
Lean mass
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
Fasting plasma glucose
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
2h postload plasma glucose
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
Fasting insulin
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
2h postload insulin
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
Triglycerides
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
Cholesterol
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
LDL cholesterol
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
HDL cholesterol
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
Total bilirubin
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
Conjugated bilirubin
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
Creatinine
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
Uric acid
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
Systolic blood pressure
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
Diastolic blood pressure
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
Waist circumference
Measured: From enrollment to the end of intervention at 2 weeks or 16 weeks
HbA1c
Measured only in long-term intermittent intervention subjects
Measured: 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
Measured: From enrollment to the end of intervention at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start18 Feb 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight/obesityStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883578
- Sponsor's protocol ID
- B2024-402R
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Valine Diet on Body Weight and Metabolic Parameters
- ClinicalTrials.gov ID
- NCT06883578
- Acronym / sponsor ID
- B2024-402R
- Keywords
- Obesity, Dietary intervention, Low valine meal replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Short-term continuous normal meal replacement intervention group | Placebo comparator | Dietary Supplement: Short-term continuous normal meal replacementThe 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 | Dietary Supplement: Short-term continuous low-valine meal replacementsThe 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 | Dietary Supplement: Long-term intermittent normal meal replacementThe 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 | Dietary Supplement: Long-term intermittent low valine meal replacementThe 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. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, 16 years old ≤ age ≤ 80 years old;
- BMI ≥ 24kg/m2
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-term continuous normal meal replacementThe 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. | Dietary supplement | Short-term continuous normal meal replacement intervention group |
| Short-term continuous low-valine meal replacementsThe 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. | Dietary supplement | Short-term continuous low valine meal replacement intervention group |
| Long-term intermittent normal meal replacementThe 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. | Dietary supplement | Long-term intermittent normal meal replacement intervention group |
| Long-term intermittent low valine meal replacementThe 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. | Dietary supplement | Long-term intermittent low valine meal replacement intervention group |
Primary outcome
Body weight
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
19 secondary outcomes
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
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
Time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks
PDFF liver fat content
Time frame: From enrollment to the end of intervention at 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-term continuous normal meal replacement, Short-term continuous low-valine meal replacements and Long-term intermittent normal meal replacement in people with Overweight/obesity and Metabolic Associated Fatty Liver Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingfeng Xia (+86 136 1182 6871, xia.mingfeng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: From enrollment to the end of intervention at 2 weeks or 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.