The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
NCT Number: NCT07549308
This study compares the effects of two calorie-restricted diets-one with whey protein supplementation and one without-and a health education control group on weight and metabolic parameters in overweight and obese individuals, with the aim of informing dietary intervention strategies for this population.
Looking for future studies?
Notify Me25 year–35 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310009, China
The prevalence of overweight and obesity has been rising globally due to lifestyle and dietary changes. According to the "Report on the Status of Nutrition and Chronic Diseases among Chinese Residents (2020)", the proportion of overweight and obese adults in China has exceeded 50%. Overweight and obesity are not only major risk factors for chronic diseases such as diabetes and cardiovascular diseases but are also closely related to the increased risk of premature death. They have become one of the most serious public health problems.
Dietary intervention is a fundamental approach to the treatment of overweight and obesity. In recent years, the impact of different dietary structures on overweight and obesity has received increasing attention from researchers. The "Chinese Guidelines for Medical Nutrition Therapy of Overweight/Obesity (2021)" points out that a high-protein diet can reduce hunger, increase satiety, and increase resting energy expenditure, which is beneficial for weight loss and improving glucose homeostasis and blood lipid levels in overweight and obese patients. Studies have shown that increasing dairy intake during energy-restricted dietary intervention may help enhance satiety and reduce more body weight and fat mass. Whey protein is the protein component retained in the supernatant during the separation and precipitation of casein, and it is rich in essential amino acids. The proportion of branched-chain amino acids in its amino acid composition pattern is relatively high, which can promote the construction and repair of human tissue structure. Studies have shown that whey protein supplements can help overweight and obese patients lose weight and body fat, maintain lean body mass, and to some extent improve cardiovascular disease risk factors such as blood pressure and blood glucose levels. However, the potential mechanisms of action are not clear. In addition, the role of whey protein in the overweight and obese population in China remains to be studied. Based on this, this project designed two dietary models: a whey protein powder-supplemented energy-restricted high-protein diet and an energy-restricted balanced diet. They were compared with a health education control group to study the effects of whey protein powder on weight and metabolic indicators in overweight and obese patients, in order to provide a reference for dietary intervention in overweight and obese patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention period lasted for 12 weeks. During this time, Participants received dietary guidance from researchers. The whey protein group underwent a 30% energy reduction diet with a macronutrient distribution of 45%-50% carbohydrates, 30% fat, and 20%-25% protein. Participants consumed 13 grams of whey protein powder twice daily, with breakfast and afternoon snacks, partially replacing staple foods.
The intervention period lasted for 12 weeks. During this time, Participants received dietary guidance from researchers. The calorie-restricted balanced diet group underwent a 30% energy reduction diet with a macronutrient distribution of 55% carbohydrates, 30% fat, and 15% protein.
The intervention period lasted for 12 weeks. During this time, Participants received dietary guidance from researchers. The health education control diet group followed an unrestricted energy healthy diet plan with a macronutrient distribution of 50% -65%carbohydrates, 20%-30% fat, and 10%-15% protein.
Time frame: Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention
Measured after fasting and voiding, without shoes, in light clothing, using a standard scale
Time frame: Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention
Measured by Bioelectrical impedance analysis
Time frame: Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention
Measured by Bioelectrical impedance analysis
Time frame: Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention
Measured by Bioelectrical impedance analysis
Time frame: Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention
Measured by Bioelectrical impedance analysis
Time frame: Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention
Measure the grip strength of the dominant hand, take the maximum value of two attempts, and record to the nearest 0.1 kg
Time frame: Change from baseline to 12 weeks
Collect fasting venous blood (after at least 8 hours of fasting) from subjects to measure fasting blood glucose
Time frame: Change from baseline to 12 weeks
Measured with the use of the homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: Change from baseline to 12 weeks
Collect fasting venous blood (after at least 8 hours of fasting) from subjects to measure fasting insulin
Time frame: Change from baseline to 12 weeks
Fasting venous blood (after 8 hours of fasting) is collected from the subjects. Serum levels of total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) are measured
Time frame: Change from baseline to 12 weeks
Collect fasting venous blood (after at least 8 hours of fasting) from subjects to measure serum creatinine (Cr) and blood urea nitrogen (BUN) . The estimated glomerular filtration rate (eGFR) is calculated using the CKD-EPI or MDRD formula based on serum creatinine, age, sex, and race.
Time frame: Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention
Using a 5-point Likert scale (Not at All, Somewhat, Moderately, Very, Extremely)
Time frame: Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention
Using a 5-point Likert scale (Not at All, Somewhat, Moderately, Very, Extremely)
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05929079
Apnea, Body Weight
Anniston, Alabama, United States
View Trial DetailsNCT00342732
Body Weight, Nutrition Disorders
Phoenix, Arizona, United States
View Trial DetailsNCT00445627
Body Weight, Diabetes Mellitus
Bethesda, Maryland, United States
View Trial DetailsNCT06904105
Body Weight, Nutrition Disorders
Beijing, Beijing Municipality, China
View Trial Details