Clinical trial NCT04552574: Randomized Clinical Trial of HMR(Home Meal Replacement)-Type Omega-3-balanced-diet
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Metabolic Disorder
Lipid Metabolism Disorders
Sarcopenia
Lead sponsor: Chungbuk National University Hospital
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 76
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lipids
timeFrame: 4 weeks
measure: triglyceride
timeFrame: 4 weeks
measure: Muscle mass
timeFrame: 4 weeks
Secondary outcomes:
measure: WBC (White blood cell) count
timeFrame: 4 weeks
measure: hsCRP (high-sensitivity C-reactive protein)
timeFrame: 4 weeks
measure: Balance between omega-3 fatty acids and omega-6 fatty acids
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
Study officials:
affiliation: Chungbuk National University Hospital
name: Jae Hyun Ahn
role: STUDY_DIRECTOR
References:
citation: 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.