ObesityNCT07549308
Effect of a Protein Supplementation on Body Weight and Metabolic Variables in Overweight and Obese Patients
A study testing whey protein powder, calorie-restricted balanced diet and health education in people with Obesity and Overweight, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- whey protein powder, calorie-restricted balanced diet and health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2024to 17 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 25-35 years old, no gender restrictions
- Body mass index (BMI) ≥ 24 kg/m²
- Voluntary consent and signed informed consent form
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
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.
Read the 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.
- Conditions
- Obesity, Overweight
- Being tested
- whey protein powder, calorie-restricted balanced diet, health education
- Keywords
- Overweight and Obesity, Whey Protein, Dietary Pattern
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey protein powderDietary 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.
calorie-restricted balanced dietBehavioural
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.
health educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: whey protein powder |
| 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. Receives: Behavioral: calorie-restricted balanced diet |
| 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. Receives: Behavioral: health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured after fasting and voiding, without shoes, in light clothing, using a standard scale
Measured: Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention
Secondary outcomes (12)
Skeletal muscle mass
Measured by Bioelectrical impedance analysis
Measured: Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention
Body fat mass
Measured by Bioelectrical impedance analysis
Measured: Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention
Body fat percentage
Measured by Bioelectrical impedance analysis
Measured: Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention
Visceral fat area
Measured by Bioelectrical impedance analysis
Measured: 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
Measured: 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
Measured: Change from baseline to 12 weeks
Insulin-resistance status
Measured with the use of the homeostasis model assessment of insulin resistance (HOMA-IR)
Measured: 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
Measured: 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
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.
Measured: Change from baseline to 12 weeks
Hunger rating
Using a 5-point Likert scale (Not at All, Somewhat, Moderately, Very, Extremely)
Measured: 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)
Measured: Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start23 Feb 2024
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549308
- Sponsor's protocol ID
- 2022-0930
- Status last verified
- Apr 2026
- First submitted
- 8 Aug 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Protein Supplementation on Body Weight and Metabolic Variables in Overweight and Obese Patients
- ClinicalTrials.gov ID
- NCT07549308
- Acronym / sponsor ID
- 2022-0930
- Conditions
- Obesity, Overweight
- Keywords
- Overweight and Obesity, Whey Protein, Dietary Pattern
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whey protein group | Experimental | Dietary Supplement: whey protein powderParticipants 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. |
| Calorie-restricted balanced diet group | Active comparator | Behavioral: calorie-restricted balanced dietParticipants 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. |
| Health education control group | Active comparator | Behavioral: health educationParticipants 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. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 25-35 years old, no gender restrictions
- Body mass index (BMI) ≥ 24 kg/m²
- Voluntary consent and signed informed consent form
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whey protein powderThe 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. | Dietary supplement | Whey protein group |
| calorie-restricted balanced dietThe 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. | Behavioural | Calorie-restricted balanced diet group |
| health educationThe 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. | Behavioural | Health education control group |
Primary outcome
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
12 secondary outcomes
Skeletal muscle mass
Time frame: Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention
Body fat mass
Time frame: Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention
Body fat percentage
Time frame: Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention
Visceral fat area
Time frame: Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention
Handgrip strength
Time frame: Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention
Fasting glucose level
Time frame: Change from baseline to 12 weeks
Insulin-resistance status
Time frame: Change from baseline to 12 weeks
Fasting insulin
Time frame: Change from baseline to 12 weeks
Serum lipids
Time frame: Change from baseline to 12 weeks
Renal function
Time frame: Change from baseline to 12 weeks
Hunger rating
Time frame: Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention
Diet Satisfaction
Time frame: Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whey protein powder, calorie-restricted balanced diet and health education in people with Obesity and Overweight, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.