Chronic Metabolic DisorderNCT04552574
Randomized Clinical Trial of HMR(Home Meal Replacement)-Type Omega-3-balanced-diet
A study testing HMR(Home meal replacement)-type omega-3-balanced diet in people with Chronic Metabolic Disorder and Lipid Metabolism Disorders, run by Chungbuk National University Hospital at 1 site in South Korea.
Trial summary
Investigate whether HMR(Home meal replacement)-type omega-3-balanced-diet can improve clinical laboratory values related to chronic metabolic diseases through reducing lipids and chronic inflammation, and can prevent muscle loss. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Metabolic Disorder, Lipid Metabolism Disorders, Sarcopenia
- What is being tested?
- HMR(Home meal replacement)-type omega-3-balanced diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Aug 2020to 31 Dec 2021
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI(Body mass index): 25-40 kg/m2
- Circumference of waist: ≥90 cm in men and ≥85 cm in women
- sBP(systolic Blood pressure): 100-180mmHg
- dBP(diastolic Blood pressure): 70-110mmHg
- Alcohol consumption: ≤14 glasses/week in men and ≤7 glasses in women
Who cannot join
- Ongoing administration of antihypertensive drugs
- Past medical history of diabetes, dyslipidemia, cardiocerebrovascular disease, or ongoing administration of drugs related to the aforementioned diseases
- Allergies to dairy products or other foods
- Smokers
- Subjects who intend to lose weight in-between during the period of clinical trial
- Abnormal at the screening blood test(AST(Aspartate transaminase), ALT(Alanine transaminase)>100 IU/L, TG(triglyceride)>400 mg/dL, total cholesterol>300 mg/dL, LDL(Low-density lipoprotein)-cholesterol>190 mg, WBC>10000/μL or <1500/μL, hsCRP>5 mg/L)
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
Yonghwan Kim, MD, +82-43-269-6060, airsantajin@gmail.com
About this study
Official title: A Clinical Trial to Identify the Effects of HMR(Home Meal Replacement)-Type Medifood on Chronic Metabolic Disorders Including Lipid Metabolism Disorders and Sarcopenia
Investigate whether HMR(Home meal replacement)-type omega-3-balanced-diet can improve clinical laboratory values related to chronic metabolic diseases through reducing lipids and chronic inflammation, and can prevent muscle loss.
Read the detailed description
Korea is entering an post-aged society with an increase in single-person households, and as the average life expectancy increases, the increase in the population exposed to chronic metabolic diseases requires basic dietary solutions for life seeking physical, mental and social well-being. As a result of a survey conducted by the Korean Health Insurance Corporation (2010), medical expenses for chronic metabolic diseases were estimated at 15,233.8 billion won, with 54.3% of adults with chronic diseases, 68.7% in their 50s, 83.7% in their 60s, and 91.3% in their 70s or older. This trend continues to increase, resulting in an increasing social burden. Our researchers focused on functional lipids which provide specific health benefits when ingested to prevent these chronic diseases. Omega 3 is an essential fatty acid that can not be synthesized in the body, maintaining the structure of cells in the human body, helping smooth metabolism. It also inhibits the aggregation of platelets and lowers the risk of coronary artery or cardiovascular disease by lowering the level of neutrality, it has been reported to have an inflammatory mitigation effect. Omega 6 has been reported to cause increased inflammation and ulticaria, asthma, cardiovascular disease side effects when intake is increased. In this context, the recommended ratio of omega 3 and omega 6 is reported to be within 1:4.
A diet of which omega-3 to omega-6 ratio is below 1:4 was developed by Agricultural entity Green Grass Co., Ltd. for prevention of sarcopenia and chronic metabolic disease.
Subjects assigned to the test group receive a total of 4 weeks HMR medifood and consume a regular diet for the next four weeks after having a wash-out period for a total of two weeks. On the other hand, subjects assigned to the control group would be able to consume a regular diet for the first four weeks and take HMR medifood for the next four weeks after having a two-week wash-out period.
- Being tested
- HMR(Home meal replacement)-type omega-3-balanced diet
- Medical subject headings
- Lipid Metabolism Disorders, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMR(Home meal replacement)-type omega-3-balanced dietDietary supplement
A diet of which omega-3 to omega-6 ratio is below 1:4 was developed by Agricultural entity Green Grass Co., Ltd.. A committee of experts that is composed of several university professors in authorities of IPET(Institute of Planning and Evaluation for Technology in food, agriculture and forestry) also participated in the development of this diet.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | All subjects will intake HMR(Home meal replacement)-type omega-3-balanced-diet for 4 weeks. Receives: Dietary Supplement: HMR(Home meal replacement)-type omega-3-balanced diet |
| Control group | No intervention | No intervention for 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipids
LDL(Low-density lipoprotein)-cholesterol and HDL(High-density lipoprotein)-cholesterol
Measured: 4 weeks
triglyceride
Lipids
Measured: 4 weeks
Muscle mass
SLM (Soft lean mass)
Measured: 4 weeks
Secondary outcomes (3)
WBC (White blood cell) count
Inflammation
Measured: 4 weeks
hsCRP (high-sensitivity C-reactive protein)
Inflammation
Measured: 4 weeks
Balance between omega-3 fatty acids and omega-6 fatty acids
Omega-3 fatty acids to omega-6 fatty acids ratio
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start19 Aug 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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 Chronic Metabolic DisorderStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonghwan Kim, Chungbuk National University Hospital
- Investigators
- Jae Hyun Ahn, Study director, Chungbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552574
- Sponsor's protocol ID
- CBNUH202006021
- Status last verified
- Sep 2020
- First submitted
- 13 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JW, Kim Y, Hyun T, Song S, Yang W, Kim YS, You HS, Chang YC, Shin SH, Kang HT. Beneficial Effects of a Specially Designed Home Meal Replacement on Cardiometabolic Parameters in Individuals with Obesity: Preliminary Results of a Randomized Controlled Clinical Trial. Nutrients. 2021 Jun 24;13(7):2171. doi: 10.3390/nu13072171.
PubMed 34202690
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Identify the Effects of HMR(Home Meal Replacement)-Type Medifood on Chronic Metabolic Disorders Including Lipid Metabolism Disorders and Sarcopenia
- ClinicalTrials.gov ID
- NCT04552574
- Acronym / sponsor ID
- CBNUH202006021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Chungbuk National University HospitalUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Sep 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.
Investigate whether HMR(Home meal replacement)-type omega-3-balanced-diet can improve clinical laboratory values related to chronic metabolic diseases through reducing lipids and chronic inflammation, and can prevent muscle loss.
Detailed description
Korea is entering an post-aged society with an increase in single-person households, and as the average life expectancy increases, the increase in the population exposed to chronic metabolic diseases requires basic dietary solutions for life seeking physical, mental and social well-being. As a result of a survey conducted by the Korean Health Insurance Corporation (2010), medical expenses for chronic metabolic diseases were estimated at 15,233.8 billion won, with 54.3% of adults with chronic diseases, 68.7% in their 50s, 83.7% in their 60s, and 91.3% in their 70s or older. This trend continues to increase, resulting in an increasing social burden. Our researchers focused on functional lipids which provide specific health benefits when ingested to prevent these chronic diseases. Omega 3 is an essential fatty acid that can not be synthesized in the body, maintaining the structure of cells in the human body, helping smooth metabolism. It also inhibits the aggregation of platelets and lowers the risk of coronary artery or cardiovascular disease by lowering the level of neutrality, it has been reported to have an inflammatory mitigation effect. Omega 6 has been reported to cause increased inflammation and ulticaria, asthma, cardiovascular disease side effects when intake is increased. In this context, the recommended ratio of omega 3 and omega 6 is reported to be within 1:4.
A diet of which omega-3 to omega-6 ratio is below 1:4 was developed by Agricultural entity Green Grass Co., Ltd. for prevention of sarcopenia and chronic metabolic disease.
Subjects assigned to the test group receive a total of 4 weeks HMR medifood and consume a regular diet for the next four weeks after having a wash-out period for a total of two weeks. On the other hand, subjects assigned to the control group would be able to consume a regular diet for the first four weeks and take HMR medifood for the next four weeks after having a two-week wash-out period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: HMR(Home meal replacement)-type omega-3-balanced dietAll subjects will intake HMR(Home meal replacement)-type omega-3-balanced-diet for 4 weeks. |
| Control group | No intervention | –No intervention for 4 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI(Body mass index): 25-40 kg/m2
- Circumference of waist: ≥90 cm in men and ≥85 cm in women
- sBP(systolic Blood pressure): 100-180mmHg
- dBP(diastolic Blood pressure): 70-110mmHg
- Alcohol consumption: ≤14 glasses/week in men and ≤7 glasses in women
Key exclusion criteria (7 listed)
- Ongoing administration of antihypertensive drugs
- Past medical history of diabetes, dyslipidemia, cardiocerebrovascular disease, or ongoing administration of drugs related to the aforementioned diseases
- Allergies to dairy products or other foods
- Smokers
- Subjects who intend to lose weight in-between during the period of clinical trial
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 |
|---|---|---|
| HMR(Home meal replacement)-type omega-3-balanced dietA diet of which omega-3 to omega-6 ratio is below 1:4 was developed by Agricultural entity Green Grass Co., Ltd.. A committee of experts that is composed of several university professors in authorities of IPET(Institute of Planning and Evaluation for Technology in food, agriculture and forestry) also participated in the development of this diet. | Dietary supplement | Intervention group |
Primary outcome
Lipids
Time frame: 4 weeks
LDL(Low-density lipoprotein)-cholesterol and HDL(High-density lipoprotein)-cholesterol
triglyceride
Time frame: 4 weeks
Lipids
Muscle mass
Time frame: 4 weeks
SLM (Soft lean mass)
3 secondary outcomes
WBC (White blood cell) count
Time frame: 4 weeks
hsCRP (high-sensitivity C-reactive protein)
Time frame: 4 weeks
Balance between omega-3 fatty acids and omega-6 fatty acids
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Derived from this study: PubMed 34202690Lee JW, Kim Y, Hyun T, Song S, Yang W, Kim YS, You HS, Chang YC, Shin SH, Kang HT. Beneficial Effects of a Specially Designed Home Meal Replacement on Cardiometabolic Parameters in Individuals with Obesity: Preliminary Results of a Randomized Controlled Clinical Trial. Nutrients. 2021 Jun 24;13(7):2171. doi: 10.3390/nu13072171.
- Individual participant dataSharing planned: No
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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.
Jae Hyun Ahn study director
Chungbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMR(Home meal replacement)-type omega-3-balanced diet in people with Chronic Metabolic Disorder and Lipid Metabolism Disorders, run by Chungbuk 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 5 inclusion and 7 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 Sep 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 Yonghwan Kim, MD (82-43-269-6060, airsantajin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipids (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 NCT04552574, 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 Sep 2020.