Obesity & Overweight
Conditions
Keywords
Weight loss, High-protein diet, Meal replacement, Calorie restriction, Body composition, Nutrition interventionMetabolic health, Randomized controlled trial, Dietary intervention
Brief summary
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
Detailed description
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. Participants will attend scheduled visits for anthropometric measurements and laboratory testing. Safety will be monitored throughout the study, including vital signs and the recording of any adverse events.
Interventions
DIETARY_SUPPLEMENTMeal Replacement and Dietary Supplementation
Participants replace two main meals per day with a protein-based meal replacement shake and take additional dietary supplements in capsule form twice daily with snacks as part of a structured, calorie-restricted diet. Participants also follow individualized meal plans tailored to their caloric needs.
BEHAVIORALCalorie-Restricted Diet
Participants follow a standard calorie-restricted diet based on general nutritional recommendations without meal replacement products or additional dietary supplements. Participants also follow individualized meal plans tailored to their caloric needs.
Sponsors
Kazakh Academy of Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Both participants and researchers are aware of group assignments.
Intervention model description
Participants will be randomly assigned to one of two parallel groups. One group will follow a structured high-protein, calorie-restricted diet with meal replacements, while the other group will follow a standard calorie-restricted diet. Participants in both groups will follow individualized meal plans tailored to their caloric needs.
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight (kg) | Baseline to 3 months | Change in body weight measured in kilograms. Body weight will be assessed at baseline and monthly during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body fat percentage (%) | Baseline to 3 months | Change in body fat percentage measured by bioimpedance analysis. Assessments will be performed at baseline and monthly during the study |
| Change in lean body mass (kg) | Baseline to 3 months | Change in lean body mass measured by bioimpedance analysis. Assessments will be performed at baseline and monthly during the study |
| Change in body mass index (BMI, kg/m²) | Baseline to 3 months | Change in body mass index calculated as weight in kilograms divided by height in meters squared. Assessments will be performed at baseline and monthly during the study |
| Change in blood glucose concentration (mmol/L) | Baseline to 3 months | Change in fasting blood glucose concentration measured in mmol/L at baseline and at 3 months |
| Change in total cholesterol (mmol/L) | Baseline to 3 months | Change in total cholesterol levels measured in mmol/L at baseline and at 3 months |
| Change in LDL cholesterol (mmol/L) | Baseline to 3 months | Change in low-density lipoprotein (LDL) cholesterol levels measured in mmol/L at baseline and at 3 months |
| Change in HDL cholesterol (mmol/L) | Baseline to 3 months | Change in high-density lipoprotein (HDL) cholesterol levels measured in mmol/L at baseline and at 3 months |
| Change in triglycerides (mmol/L) | Baseline to 3 months | Change in triglyceride levels measured in mmol/L at baseline and at 3 months |
| Change in appetite-related scores assessed by Visual Analog Scale (VAS) | Baseline to 3 months | Change in self-reported appetite-related sensations assessed using a Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates minimal intensity and 10 indicates maximal intensity of the measured sensation. The questionnaire includes multiple domains such as hunger, satiety, desire to eat, food intake capacity, food satisfaction, cravings, emotional influence on eating, and dietary control. Assessments will be performed at baseline and monthly during the study |
Countries
Kazakhstan
Contacts
STUDY_DIRECTORAliya Kaldybai
Kazakh Academy of Nutrition, Almaty, Kazakhstan
Outcome results
None listed