Evaluation of the Effectiveness of a High-Protein Diet With Meal Replacement and Dietary Supplementation in a Weight Management Program
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in body weight (kg)
研究概览
简要总结
The goal of this clinical trial is to learn if a structured high-protein diet with meal replacements can help with weight loss in adults with overweight or obesity. The main questions it aims to answer are:
Does this diet help participants lose more body weight? Does this diet improve body composition and blood markers such as glucose and cholesterol?
Researchers will compare a structured diet program with meal replacements to a standard low-calorie diet to see if it leads to better weight loss and health outcomes.
Participants will:
Follow a calorie-restricted diet for the duration of the study Be assigned to either a meal replacement program or a standard diet Attend study visits for body measurements and blood tests Report their feelings of hunger and fullness
详细描述
This randomized, controlled clinical trial is designed to evaluate the effectiveness of a structured, high-protein, calorie-restricted diet that includes standardized protein-based meal replacement products and additional dietary supplements in capsule form compared to a standard low-calorie diet in adults with overweight or obesity.
Approximately 60 participants aged 25 to 60 years will be enrolled and randomly assigned to one of two groups. The intervention group will follow a structured nutrition program that includes replacing two main meals per day with a protein-based meal replacement shake and taking additional dietary supplements in capsule form twice daily with snacks. The control group will follow a conventional calorie-restricted diet based on general nutritional recommendations without meal replacement products or additional dietary supplements.
Participants in both groups will follow individualized meal plans tailored to their caloric needs.
Daily energy intake in both groups will be approximately 1400-1600 kcal, with an estimated energy deficit of about 500 kcal. Protein intake is expected to be higher in the intervention group compared to the control group.
The primary outcomes of the study include changes in body weight, body mass index, and body composition assessed by bioimpedance analysis. Secondary outcomes include metabolic parameters such as glucose, insulin, and lipid profile, as well as subjective measures including hunger, satiety, and overall well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. Both participants and researchers are aware of group assignments.
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 25 to 60 years
- •Overweight or obesity
- •Ability to provide informed consent
- •Willingness to follow a calorie-restricted diet program
- •Willingness to comply with study procedures
排除标准
- •Pregnancy or breastfeeding
- •Women of reproductive potential who are not using reliable contraception during the study
- •Severe or uncontrolled cardiovascular disease, including recent myocardial infarction or stroke within the past 6 months, unstable angina, or heart failure
- •Uncontrolled arterial hypertension at screening
- •Severe renal impairment
- •Severe hepatic dysfunction
- •Diabetes requiring insulin therapy or uncontrolled diabetes
- •Active oncological disease or cancer treatment within the past 12 months
- •Acute or chronic inflammatory disease in the acute stage
- •History of gastrointestinal or bariatric surgery affecting absorption or body weight within the past 12 months
- •Severe pulmonary disease in the stage of decompensation Allergy or intolerance to components of the study products, including milk proteins or lactose-containing products Current use of medications or dietary supplements that significantly affect body weight, if discontinuation before study start is not possible Participation in another interventional clinical study within the past 3 months Inability to provide informed consent or comply with the study protocol Significant body weight change, defined as more than 5% gain or loss, within the past 3 months before screening Severe psychiatric disorders or eating disorders that may interfere with participation Active alcohol or substance dependence Chronic use of systemic glucocorticoids or other medications affecting body weight, if discontinuation is not appropriate Planned pregnancy during the study period Uncontrolled thyroid disease Acute infection or febrile illness at screening Clinically significant abnormal laboratory findings at screening that, in the investigator's opinion, make participation unsafe
研究组 & 干预措施
High-Protein Diet with Meal Replacements
Participants follow a structured, calorie-restricted, high-protein diet that includes replacing two main meals per day with a protein-based meal replacement shake and taking additional dietary supplements in capsule form twice daily with snacks. Participants also receive individualized meal plans tailored to their caloric needs.
干预措施: Meal Replacement and Dietary Supplementation (Dietary Supplement)
Standard Low-Calorie Diet
Participants follow a standard calorie-restricted diet based on general nutritional recommendations without meal replacement products. Participants also receive individualized meal plans tailored to their caloric needs.
干预措施: Calorie-Restricted Diet (Behavioral)
结局指标
主要结局
Change in body weight (kg)
时间窗: Baseline to 3 months
Change in body weight measured in kilograms. Body weight will be assessed at baseline and monthly during the study
次要结局
- Change in body fat percentage (%)(Baseline to 3 months)
- Change in lean body mass (kg)(Baseline to 3 months)
- Change in body mass index (BMI, kg/m²)(Baseline to 3 months)
- Change in blood glucose concentration (mmol/L)(Baseline to 3 months)
- Change in total cholesterol (mmol/L)(Baseline to 3 months)
- Change in LDL cholesterol (mmol/L)(Baseline to 3 months)
- Change in HDL cholesterol (mmol/L)(Baseline to 3 months)
- Change in triglycerides (mmol/L)(Baseline to 3 months)
- Change in appetite-related scores assessed by Visual Analog Scale (VAS)(Baseline to 3 months)