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Obesity & OverweightNCT07547722

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

A study testing Meal Replacement and Dietary Supplementation and Calorie-Restricted Diet in people with Obesity & Overweight, run by Kazakh Academy of Nutrition at 1 site in Kazakhstan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 25 to 60 years
Conditions the study is for
Obesity & Overweight
What is being tested?
Meal Replacement and Dietary Supplementation and Calorie-Restricted Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteKazakhstan
Study dates
1 Apr 2026to Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site

  • Kazakh Academy of Nutrition LLP

    Almaty, 050010

Other trials in Kazakhstan

About this study

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

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?

Read more

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

Read the 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.

Being tested
Meal Replacement and Dietary Supplementation, Calorie-Restricted Diet
Keywords
Weight loss, High-protein diet, Meal replacement, Calorie restriction, Body composition, Nutrition interventionMetabolic health, Randomized controlled trial, Dietary intervention
Medical subject headings
Obesity, Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meal Replacement and Dietary SupplementationDietary 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.

  • Calorie-Restricted DietBehavioural

    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.

Study groups in NCT07547722
Study groupRoleWhat they receive
High-Protein Diet with Meal ReplacementsExperimentalParticipants 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.
Receives: Dietary Supplement: Meal Replacement and Dietary Supplementation
Standard Low-Calorie DietActive comparatorParticipants 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.
Receives: Behavioral: Calorie-Restricted Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline to 3 months

Secondary outcomes (9)

  1. Change in body fat percentage (%)

    Change in body fat percentage measured by bioimpedance analysis. Assessments will be performed at baseline and monthly during the study

    Measured: Baseline to 3 months

  2. Change in lean body mass (kg)

    Change in lean body mass measured by bioimpedance analysis. Assessments will be performed at baseline and monthly during the study

    Measured: Baseline to 3 months

  3. Change in body mass index (BMI, kg/m²)

    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

    Measured: Baseline to 3 months

  4. Change in blood glucose concentration (mmol/L)

    Change in fasting blood glucose concentration measured in mmol/L at baseline and at 3 months

    Measured: Baseline to 3 months

  5. Change in total cholesterol (mmol/L)

    Change in total cholesterol levels measured in mmol/L at baseline and at 3 months

    Measured: Baseline to 3 months

  6. Change in LDL cholesterol (mmol/L)

    Change in low-density lipoprotein (LDL) cholesterol levels measured in mmol/L at baseline and at 3 months

    Measured: Baseline to 3 months

  7. Change in HDL cholesterol (mmol/L)

    Change in high-density lipoprotein (HDL) cholesterol levels measured in mmol/L at baseline and at 3 months

    Measured: Baseline to 3 months

  8. Change in triglycerides (mmol/L)

    Change in triglyceride levels measured in mmol/L at baseline and at 3 months

    Measured: Baseline to 3 months

  9. Change in appetite-related scores assessed by Visual Analog Scale (VAS)

    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

    Measured: Baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start1 Apr 2026
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07547722
Sponsor's protocol ID
HPD15048
Other IDs
15048
Status last verified
Apr 2026
First submitted
17 Apr 2026
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations and the absence of a predefined data sharing plan.

Questions about this trial

What is this clinical trial studying?

A study testing Meal Replacement and Dietary Supplementation and Calorie-Restricted Diet in people with Obesity & Overweight, run by Kazakh Academy of Nutrition at 1 site in Kazakhstan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight (kg) (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07547722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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