Effect of a Protein Supplementation on Body Weight and Metabolic Variables in Overweight and Obese Patients
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Body weight
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 25-35 years old, no gender restrictions
- •Body mass index (BMI) ≥ 24 kg/m²
- •Voluntary consent and signed informed consent form
Exclusion Criteria
- •Age \< 25 years or \> 35 years
- •Current use of medications that may affect weight or energy balance (e.g., lipid-lowering drugs, antidiabetic drugs, appetite suppressants), or other protein supplements
- •Presence of acute or chronic viral hepatitis, abnormal liver function (ALT or/and AST \> 3 times the upper limit of normal), kidney disease (serum creatinine \> upper limit of normal), diabetes, malignant tumors, or cardiovascular diseases
- •Gastrointestinal disorders that affect food digestion and absorption (e.g., chronic diarrhea, constipation, severe gastrointestinal inflammation, active peptic ulcer disease, post-gastrointestinal surgery)
- •Psychiatric disorders
- •Allergies to product ingredients or presence of inborn metabolic disorders
- •Pregnancy or lactation
- •Other conditions deemed unsuitable for participation in the study by the researchers (e.g., severe diseases not listed in the exclusion criteria)
Arms & Interventions
Whey protein group
Participants in the whey protein group underwent a 30% reduction in their average energy intake. They consumed whey protein powder twice daily (13 grams each) with breakfast and afternoon snacks, partially replacing staple foods. The macronutrient distribution for this group was as follows:
Carbohydrates: 45%-50% of energy intake Protein: 20%-25% of energy intake Fat: 30% of energy intake The energy-restricted diet lasted for 12 weeks. During this period, clinical nutritionists monitored participants' dietary intake and exercise habits twice a week via WeChat/phone calls. Participants had outpatient visits every 4 weeks for dietary and exercise monitoring and guidance.
Intervention: whey protein powder (Dietary Supplement)
Calorie-restricted balanced diet group
Participants in the energy-restricted balanced diet group underwent a 30% reduction in their average energy intake. The macronutrient distribution for this group was as follows:
Carbohydrates: 55% of energy intake Protein: 15% of energy intake Fat: 30% of energy intake The energy-restricted diet lasted for 12 weeks. During this period, clinical nutritionists monitored participants' dietary intake and exercise habits twice a week via WeChat/phone calls. Participants had outpatient visits every 4 weeks for dietary and exercise monitoring and guidance.
Intervention: calorie-restricted balanced diet (Behavioral)
Health education control group
Participants in the health education control group followed an unrestricted energy healthy diet plan. The macronutrient distribution for this group was as follows:
Carbohydrates: 50%-65% of energy intake Protein: 10%-15% of energy intake Fat: 20%-30% of energy intake The intervention lasted for 12 weeks. During this period, clinical nutritionists monitored participants' dietary intake and exercise habits twice a week via WeChat/phone calls. Participants had outpatient visits every 4 weeks for healthy diet and exercise guidance.
Intervention: health education (Behavioral)
Outcomes
Primary Outcomes
Body weight
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
Secondary Outcomes
- Skeletal muscle mass(Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention)
- Body fat mass(Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention)
- Body fat percentage(Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention)
- Visceral fat area(Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention)
- Handgrip strength(Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention)
- Fasting glucose level(Change from baseline to 12 weeks)
- Insulin-resistance status(Change from baseline to 12 weeks)
- Fasting insulin(Change from baseline to 12 weeks)
- Serum lipids(Change from baseline to 12 weeks)
- Renal function(Change from baseline to 12 weeks)
- Hunger rating(Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention)
- Diet Satisfaction(Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention)