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

NCT ID: NCT04552574

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-19
• Study Completion Date: 2021-12-31

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.

Conditions

Chronic Metabolic Disorder; Lipid Metabolism Disorders; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

All subjects will intake HMR(Home meal replacement)-type omega-3-balanced-diet for 4 weeks.

Group Type: EXPERIMENTAL

HMR(Home meal replacement)-type omega-3-balanced diet

Intervention Type: DIETARY_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.

Control group

No intervention for 4 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chungbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yonghwan Kim

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jae Hyun Ahn

Role: STUDY_DIRECTOR

Chungbuk National University Hospital

Locations

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Yonghwan Kim, MD

Role: CONTACT

airsantajin@gmail.com

82-43-269-6060

Facility Contacts

Yonghwan Kim, MD

Role: primary

airsantajin@gmail.com

+82-43-269-6060

References

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.

Reference Type: DERIVED

PMID: 34202690 (View on PubMed)

Other Identifiers

CBNUH202006021

Identifier Type: -

Identifier Source: org_study_id