Randomized Study of Low Valine Meal Replacements for Weight Loss and Metabolic Health in Overweight and Obese Adults

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 122 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.

Effect of Low Valine Diet on Body Weight and Metabolic Parameters