Chronic Metabolic Disorder, Lipid Metabolism Disorders, Sarcopenia
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTHMR(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.
Sponsors
Chungbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactYonghwan Kim, MD
Outcome results
None listed