Randomized Clinical Trial of HMR(Home Meal Replacement)-Type Omega-3-balanced-diet
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group All subjects will intake HMR(Home meal replacement)-type omega-3-balanced-diet for 4 weeks. |
Dietary Supplement: HMR(Home meal replacement)-type omega-3-balanced diet
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.
|
| No Intervention: Control group No intervention for 4 weeks. |
Outcome Measures
Primary Outcome Measures
- Lipids [4 weeks]
LDL(Low-density lipoprotein)-cholesterol and HDL(High-density lipoprotein)-cholesterol
- triglyceride [4 weeks]
Lipids
- Muscle mass [4 weeks]
SLM (Soft lean mass)
Secondary Outcome Measures
- WBC (White blood cell) count [4 weeks]
Inflammation
- hsCRP (high-sensitivity C-reactive protein) [4 weeks]
Inflammation
- Balance between omega-3 fatty acids and omega-6 fatty acids [4 weeks]
Omega-3 fatty acids to omega-6 fatty acids ratio
Eligibility Criteria
Criteria
Inclusion Criteria:
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BMI(Body mass index): 25-40 kg/m2
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Circumference of waist: ≥90 cm in men and ≥85 cm in women
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sBP(systolic Blood pressure): 100-180mmHg
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dBP(diastolic Blood pressure): 70-110mmHg
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Alcohol consumption: ≤14 glasses/week in men and ≤7 glasses in women
Exclusion Criteria:
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Ongoing administration of antihypertensive drugs
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Past medical history of diabetes, dyslipidemia, cardiocerebrovascular disease, or ongoing administration of drugs related to the aforementioned diseases
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Allergies to dairy products or other foods
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Smokers
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Subjects who intend to lose weight in-between during the period of clinical trial
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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)
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Pregnant or breastfeeding women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chungbuk National University Hospital | Cheongju | Chungcheongbuk-do | Korea, Republic of | 28644 |
Sponsors and Collaborators
- Chungbuk National University Hospital
Investigators
- Study Director: Jae Hyun Ahn, Chungbuk National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CBNUH202006021