Effect of Low Valine Diet on Body Weight and Metabolic Parameters

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Diseases; Metabolic Associated Fatty Liver Disease; Overweight/obesity
• Intervention / Treatment: Dietary supplement: Short-term continuous normal meal replacement; Dietary supplement: Short-term continuous low-valine meal replacements; Dietary supplement: Long-term intermittent normal meal replacement; Dietary supplement: Long-term intermittent low valine meal replacement

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingfeng Xia; Phone Number: +86 136 1182 6871; Email: xia.mingfeng@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Mingfeng Xia; Phone Number: +86 136 1182 6871; Email: xia.mingfeng@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Short-term continuous normal meal replacement intervention group; 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.	Dietary supplement: 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.
Experimental: Short-term continuous low valine meal replacement intervention group; 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.	Dietary supplement: 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.
Placebo Comparator: Long-term intermittent normal meal replacement intervention group; 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.	Dietary supplement: 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.
Experimental: Long-term intermittent low valine meal replacement intervention group; 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body weight	From enrollment to the end of intervention at 2 weeks or 16 weeks

Secondary Outcome Measures

Outcome Measure	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		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

Other Outcome Measures

Outcome Measure	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
Serum lipidomic profiles	From enrollment to the end of intervention at 2 weeks or 16 weeks

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: March 9, 2025
• First Submitted That Met QC Criteria: March 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 15, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Dietary intervention; Low valine meal replacement
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Digestive System Diseases; Overweight; Body Weight; Liver Diseases; Fatty Liver; Metabolic Diseases
• Other Study ID Numbers: B2024-402R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No