ObesityNCT04597788
Efficacy of Protein Supplemented Very Low Calorie Meals on Weight Loss
A study testing Protein supplemented very low calorie diet program and Conventional low calorie diet program in people with Obesity and Sarcopenic Obesity, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This randomized clinical trial will evaluate the efficacy and safety of protein supplemented very low calorie meals on weight loss and weight loss maintenance among people with obesity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Sarcopenic Obesity
- What is being tested?
- Protein supplemented very low calorie diet program and Conventional low calorie diet program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Nov 2020to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI ) more than 25 kg/m2 or
- Waist circumference more than 90 cm in men or 85 cm in women
Who cannot join
- History of treatment with anti-obesity drugs or participation in another weight loss program in previous 6 months
- Weight changes more than 3 kg during the 6 months before participation
- Unstable cardiovascular events during the 6 months before participation
- Uncontrolled mood disorder
- History of eating disorder
- History of alcohol use disorder
- History of gallstone
- Chronic renal failure (estimated glomerular filtration less than 30 ml/min)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: The Role of Protein Supplemented Very Low Calorie Medical Meals on Weight and Metabolic Changes Among People With Obesity: a Randomized Controlled Trial
This randomized clinical trial will evaluate the efficacy and safety of protein supplemented very low calorie meals on weight loss and weight loss maintenance among people with obesity.
Read the detailed description
Approximately 30% of the Korean population has obesity or abdominal obesity and is often accompanied by obesity related complications such as cardiovascular disease, diabetes, osteoarthritis and even some types of cancer. However, there are not many lifestyle modification treatments available that have long-term effects other than drugs and surgical treatments in the management of obesity.
Preserving muscle mass should also be considered in weight loss especially for elderly adults with obesity, because decreased muscle mass and strength can negatively affect morbidity and mortality in the elderly.
Therefore, the investigators want to evaluate the effectiveness and safety of the protein supplemented very low calorie meals on weight loss, body composition as well as metabolic changes compared with traditional low calorie low fat diet in people with obesity.
- Conditions
- Obesity, Sarcopenic Obesity
- Being tested
- Protein supplemented very low calorie diet program, Conventional low calorie diet program
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplemented very low calorie diet programOther
Protein supplemented very low calorie meal is a shake-type meal replacement with total calories of 600 to 800 calories per day and proteins provided at 1.2g of ideal body weight per day. The four-month, very low calorie diet program schedule will be as follows. In the first two weeks, all three meals are replaced, followed by two meals replaced and one meal in food in the next six weeks, and one meal replacement is recommended for the next eight weeks. For the next eight months, the intermittent very low calorie meal replacements will be provided regularly for one week a month. If a subject gains weight more than 2kg, he or she will have an additional 1 week of two meal replacements, and if a subject gains weight more than 4kg, he or she should have an additional 2 weeks of replacement.
Individual sessions will be held 11 times during the study. Mobile counseling with dietitians or nurses will be offered to help subjects lose weight and maintain weight loss.
Conventional low calorie diet programOther
Low calorie diet consists of 1200 to 1500 calories will be educated and lifestyle modification will be encouraged for participants in control group. Educational materials as well as recipes for low calorie diet will be provided in individual sessions. Mobile counseling will also be offered for sticking to the diet program.
| Study group | Role | What they receive |
|---|---|---|
| Protein supplemented very low calorie diet program | Experimental | The lifestyle intervention using protein supplemented very low calorie meals will be implemented with individual counseling sessions for 12 months. Initial intensive weight loss stage will be delivered during the first 4 month period with total meal replacement to partial meal replacement using protein supplemented very low calorie meals. During the weight loss maintenance stage, regular intermittent very low calorie meal replacement one week per month will be delivered for the entire period. Mobile counseling will be offered to help patients achieve weight loss as well as weight loss maintenance. Receives: Other: Protein supplemented very low calorie diet program |
| Conventional low calorie diet program | Active comparator | The conventional low calorie diet program will be offered to participants assigned to control group using educational material and individual counseling sessions for 12 months. Mobile counseling will be also offered for weight loss and weight loss maintenance. Receives: Other: Conventional low calorie diet program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in weight
Changes of weight loss from the baseline expressed as kg
Measured: 12 months
Secondary outcomes (9)
Changes in body composition
Changes in muscle mass and fat mass from the baseline expressed as kg using bioelectrial impedance analysis (Inbody Co., Seoul, Korea)
Measured: 12 months
Changes in systolic and diastolic blood pressure
Changes in systolic and diastolic blood pressure from the baseline expressed as mmHg
Measured: 12 months
Changes in triglyceride
Changes in triglyceride from the baseline expressed as mg/dL
Measured: 12 months
Changes in glucose
Changes in glucose from the baseline expressed as mg/dL
Measured: 12 months
Changes in high density lipoprotein (HDL) Cholesterol
Changes in HDL cholesterol from the baseline expressed as mg/dL
Measured: 12 months
Changes in low density lipoprotein (LDL) Cholesterol
Changes in LDL cholesterol from the baseline expressed as mg/dL
Measured: 12 months
Changes in liver enzyme
Changes in aspartate and alanine aminotransferase, gamma glutamyltransferase (AST and ALT, GGT) from the baseline expressed as IU/L
Measured: 12 months
Changes in insulin resistance
Changes in insulin resistance using the homeostatic model assessment for insulin resistance (HOMA-IR) as HOMA-IR =insulin(uIU/ml) * fasting glucose (mg/dL)*0.05551/22.5
Measured: 12 months
Changes in obesity related quality of life
Changes in Korean version of obesity related quality of life scales (published in Korean Society for the Study of Obesity 2003;12(4):280-293 )
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start16 Nov 2020 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597788
- Sponsor's protocol ID
- B-2004-604-003
- Status last verified
- Jul 2020
- First submitted
- 3 Sep 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cho E, Kim S, Kim HJ, Cho B, Park JH, Kwon H, Kim JY, Go Y, Kang DG, Shin E, Lee S, Gil S, Kim H, Ahn J, Kim JY, Jung W, Go E. Effectiveness of a protein-supplemented very-low-calorie diet program for weight loss: a randomized controlled trial in South Korea. Front Nutr. 2024 Sep 12;11:1370737. doi: 10.3389/fnut.2024.1370737. eCollection 2024.
PubMed 39328464
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Protein Supplemented Very Low Calorie Medical Meals on Weight and Metabolic Changes Among People With Obesity: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04597788
- Acronym / sponsor ID
- B-2004-604-003
- Conditions
- Obesity, Sarcopenic Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- 16 Nov 2020 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial will evaluate the efficacy and safety of protein supplemented very low calorie meals on weight loss and weight loss maintenance among people with obesity.
Detailed description
Approximately 30% of the Korean population has obesity or abdominal obesity and is often accompanied by obesity related complications such as cardiovascular disease, diabetes, osteoarthritis and even some types of cancer. However, there are not many lifestyle modification treatments available that have long-term effects other than drugs and surgical treatments in the management of obesity.
Preserving muscle mass should also be considered in weight loss especially for elderly adults with obesity, because decreased muscle mass and strength can negatively affect morbidity and mortality in the elderly.
Therefore, the investigators want to evaluate the effectiveness and safety of the protein supplemented very low calorie meals on weight loss, body composition as well as metabolic changes compared with traditional low calorie low fat diet in people with obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein supplemented very low calorie diet program | Experimental | Other: Protein supplemented very low calorie diet programThe lifestyle intervention using protein supplemented very low calorie meals will be implemented with individual counseling sessions for 12 months. Initial intensive weight loss stage will be delivered during the first 4 month period with total meal replacement to partial meal replacement using protein supplemented very low calorie meals. During the weight loss maintenance stage, regular intermittent very low calorie meal replacement one week per month will be delivered for the entire period. Mobile counseling will be offered to help patients achieve weight loss as well as weight loss maintenance. |
| Conventional low calorie diet program | Active comparator | Other: Conventional low calorie diet programThe conventional low calorie diet program will be offered to participants assigned to control group using educational material and individual counseling sessions for 12 months. Mobile counseling will be also offered for weight loss and weight loss maintenance. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI ) more than 25 kg/m2 or
- Waist circumference more than 90 cm in men or 85 cm in women
Key exclusion criteria (8 listed)
- History of treatment with anti-obesity drugs or participation in another weight loss program in previous 6 months
- Weight changes more than 3 kg during the 6 months before participation
- Unstable cardiovascular events during the 6 months before participation
- Uncontrolled mood disorder
- History of eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein supplemented very low calorie diet programProtein supplemented very low calorie meal is a shake-type meal replacement with total calories of 600 to 800 calories per day and proteins provided at 1.2g of ideal body weight per day. The four-month, very low calorie diet program schedule will be as follows. In the first two weeks, all three meals are replaced, followed by two meals replaced and one meal in food in the next six weeks, and one meal replacement is recommended for the next eight weeks. For the next eight months, the intermittent very low calorie meal replacements will be provided regularly for one week a month. If a subject gains weight more than 2kg, he or she will have an additional 1 week of two meal replacements, and if a subject gains weight more than 4kg, he or she should have an additional 2 weeks of replacement. Individual sessions will be held 11 times during the study. Mobile counseling with dietitians or nurses will be offered to help subjects lose weight and maintain weight loss. | Other | Protein supplemented very low calorie diet program |
| Conventional low calorie diet programLow calorie diet consists of 1200 to 1500 calories will be educated and lifestyle modification will be encouraged for participants in control group. Educational materials as well as recipes for low calorie diet will be provided in individual sessions. Mobile counseling will also be offered for sticking to the diet program. | Other | Conventional low calorie diet program |
Primary outcome
Changes in weight
Time frame: 12 months
Changes of weight loss from the baseline expressed as kg
9 secondary outcomes
Changes in body composition
Time frame: 12 months
Changes in systolic and diastolic blood pressure
Time frame: 12 months
Changes in triglyceride
Time frame: 12 months
Changes in glucose
Time frame: 12 months
Changes in high density lipoprotein (HDL) Cholesterol
Time frame: 12 months
Changes in low density lipoprotein (LDL) Cholesterol
Time frame: 12 months
Changes in liver enzyme
Time frame: 12 months
Changes in insulin resistance
Time frame: 12 months
Changes in obesity related quality of life
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 39328464Cho E, Kim S, Kim HJ, Cho B, Park JH, Kwon H, Kim JY, Go Y, Kang DG, Shin E, Lee S, Gil S, Kim H, Ahn J, Kim JY, Jung W, Go E. Effectiveness of a protein-supplemented very-low-calorie diet program for weight loss: a randomized controlled trial in South Korea. Front Nutr. 2024 Sep 12;11:1370737. doi: 10.3389/fnut.2024.1370737. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein supplemented very low calorie diet program and Conventional low calorie diet program in people with Obesity and Sarcopenic Obesity, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ju Young Kim, MD, PhD ((82)1036964218, kkamduri@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in weight (time frame: 12 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 NCT04597788, which also lists 1 linked publication.
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 22 Oct 2020.