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ACTIVE NOT RECRUITING

NCT07547722

Effect of a High-Protein Diet With Meal Replacements on Weight Loss

Sponsor: Kazakh Academy of Nutrition

View on ClinicalTrials.gov

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

Official title: Evaluation of the Effectiveness of a High-Protein Diet With Meal Replacement and Dietary Supplementation in a Weight Management Program

Key Details

Gender

All

Age Range

25 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-01

Completion Date

2026-07

Last Updated

2026-05-06

Healthy Volunteers

Conditions

Obesity & Overweight

Interventions

DIETARY_SUPPLEMENT

Meal 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.

BEHAVIORAL

Calorie-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.

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

Locations (1)

Kazakh Academy of Nutrition LLP

Almaty, Kazakhstan