Randomized Clinical Trial of HMR(Home Meal Replacement)-Type Omega-3-balanced-diet

Sarcopenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04552574
• Other study ID #: CBNUH202006021
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2020
• Source: Chungbuk National University Hospital
• Contact: Yonghwan Kim, MD
• Phone: 82-43-269-6060
• Email: airsantajin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Metabolic Disorder
• Disease
• Lipid Metabolism Disorders
• Metabolic Diseases
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Cheongju	Chungcheongbuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chungbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipids	LDL(Low-density lipoprotein)-cholesterol and HDL(High-density lipoprotein)-cholesterol	4 weeks
Primary	triglyceride	Lipids	4 weeks
Primary	Muscle mass	SLM (Soft lean mass)	4 weeks
Secondary	WBC (White blood cell) count	Inflammation	4 weeks
Secondary	hsCRP (high-sensitivity C-reactive protein)	Inflammation	4 weeks
Secondary	Balance between omega-3 fatty acids and omega-6 fatty acids	Omega-3 fatty acids to omega-6 fatty acids ratio	4 weeks