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

NCT07547722 | Active Not Recruiting

• 2 other identifiers: HPD1504815048
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity & Overweight

Keywords

Weight loss; High-protein diet; Meal replacement; Calorie restriction; Body composition; Nutrition interventionMetabolic health; Randomized controlled trial; Dietary intervention

Outcome Measures

Primary Outcomes (1)

• Change in body weight (kg)

  Change in body weight measured in kilograms. Body weight will be assessed at baseline and monthly during the study

  Baseline to 3 months

Secondary Outcomes (9)

• 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

Study Arms (2)

High-Protein Diet with Meal Replacements

EXPERIMENTAL

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.

Dietary Supplement: Meal Replacement and Dietary Supplementation

Standard Low-Calorie Diet

ACTIVE COMPARATOR

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.

Behavioral: Calorie-Restricted Diet

Interventions

Meal Replacement and Dietary Supplementation DIETARY_SUPPLEMENT

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.

High-Protein Diet with Meal Replacements

Calorie-Restricted Diet BEHAVIORAL

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.

Standard Low-Calorie Diet

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kazakh Academy of Nutrition: lead

Study Sites (1)

Kazakh Academy of Nutrition LLP

Almaty, 050010, Kazakhstan

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Interventions

Dietary Supplements; Caloric Restriction

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena

Study Officials

• Aliya Kaldybai

  Kazakh Academy of Nutrition, Almaty, Kazakhstan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Both participants and researchers are aware of group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)