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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein group | Experimental | 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. |
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| Calorie-restricted balanced diet group | Active Comparator | 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. |
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| Health education control group | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| whey protein powder | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Measured after fasting and voiding, without shoes, in light clothing, using a standard scale | Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal muscle mass | Measured by Bioelectrical impedance analysis | Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention |
| Body fat mass | Measured by Bioelectrical impedance analysis |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
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| calorie-restricted balanced diet | Behavioral | 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. |
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| health education | Behavioral | 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. |
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| Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention |
| Body fat percentage | Measured by Bioelectrical impedance analysis | Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention |
| Visceral fat area | Measured by Bioelectrical impedance analysis | Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention |
| Handgrip strength | Measure the grip strength of the dominant hand, take the maximum value of two attempts, and record to the nearest 0.1 kg | Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention |
| Fasting glucose level | Collect fasting venous blood (after at least 8 hours of fasting) from subjects to measure fasting blood glucose | Change from baseline to 12 weeks |
| Insulin-resistance status | Measured with the use of the homeostasis model assessment of insulin resistance (HOMA-IR) | Change from baseline to 12 weeks |
| Fasting insulin | Collect fasting venous blood (after at least 8 hours of fasting) from subjects to measure fasting insulin | Change from baseline to 12 weeks |
| Serum lipids | 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 | Change from baseline to 12 weeks |
| Renal function | 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. | Change from baseline to 12 weeks |
| Hunger rating | Using a 5-point Likert scale (Not at All, Somewhat, Moderately, Very, Extremely) | Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention |
| Diet Satisfaction | Using a 5-point Likert scale (Not at All, Somewhat, Moderately, Very, Extremely) | Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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