Effect of a Protein Supplementation on Body Weight and Metabolic Variables in Overweight and Obes… (NCT07549308) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Protein Supplementation on Body Weight and Metabolic Variables in Overweight and Obese Patients
China110 participantsStarted 2024-02-23
Plain-language 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.
Who can participate
Age range25 Years – 35 Years
SexALL
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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)
What they're measuring
1
Body weight
Timeframe: Baseline; after 4-week intervention; after 8-week intervention;after 12-week intervention
Trial details
NCT IDNCT07549308
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University