Actively Recruiting
Effect of Low Valine Diet on Body Weight and Metabolic Parameters
Led by Shanghai Zhongshan Hospital · Updated on 2025-03-19
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the effects of low valine meal replacements compared to ordinary meal replacements on weight loss and metabolic health in overweight and obese individuals. The study is a randomized, double-blind, controlled clinical trial designed to assess how these diets impact body weight and related metabolic diseases. Participants include overweight or obese adults aged 16 to 80 years. The study has two parts: a short-term continuous intervention lasting 2 weeks and a long-term intermittent intervention lasting 16 weeks. Participants will be randomly assigned to either a low valine meal replacement group or a normal meal replacement group. Both types of meal replacements provide the same calorie intake based on body weight, with meals distributed in a 1:2:2 calorie ratio across breakfast, lunch, and dinner. The short-term group will consume the meal replacements daily for 2 weeks, while the long-term group will consume them for 2 consecutive days per week over 16 weeks. Participants will have their body weight measured at the start and end of the intervention. Additional assessments include plasma glucose, serum lipid profiles, liver enzymes, and body composition using DXA scans. For the long-term group, liver fat content will be measured. Researchers will also analyze serum proteomic, metabolomic, and lipidomic profiles to investigate potential mechanisms behind the effects of the low valine diet. The study includes safety monitoring and follow-up during the intervention periods.
CONDITIONS
Brief Title
Effect of Low Valine Diet on Body Weight and Metabolic Parameters
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged between 16 and 80 years
- Body mass index (BMI) of 24 kg/m2 or higher
You will not qualify if you...
- Excessive alcohol consumption: more than 140g per week for men or 70g per week for women in the past 6 months
- Liver diseases caused by other reasons, such as alcoholic liver disease, viral hepatitis, immune hepatitis, cirrhosis, or liver cancer
- Diseases affecting glucose and lipid metabolism, including hyperthyroidism, hypothyroidism, and Cushing's syndrome
- Poorly controlled diabetes with HbA1c over 9.5% in the past 3 months or use of hypoglycemic drugs affecting weight
- Chronic kidney disease or severe renal impairment with serum creatinine over 2.0mg/dL
- Serum ALT levels greater than three times the normal upper limit
- Life expectancy less than 3 years due to serious health conditions
- Planning pregnancy in the near future
- Unable to participate in follow-up during the intervention
- Continuous use of drugs that may cause weight changes for more than 2 weeks in the past year, such as glucocorticoids or thyroid hormones
- Participation in other clinical trials within the past 4 weeks
- History of gastric volume reduction or digestive tract surgery
- Diagnosis of any tumor disease
- Participation in strenuous exercise or planned diet changes
- Unable to sign the informed consent form
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants follow a low valine meal replacement diet calculated at 25 kcal/kg body weight per day, divided for breakfast, lunch, and dinner, for 2 consecutive weeks.
Multiple visits during the 2-week intervention period
Duration - 16 weeks
Participants follow a low valine meal replacement diet calculated at 25 kcal/kg body weight per day for 2 consecutive days each week, with the calorie ratio for meals as 1:2:2, continuing for 16 weeks.
Weekly visits for up to 16 weeks
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200031
Actively Recruiting
Research Team
M
Mingfeng Xia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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