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

A Clinical Trial to Identify the Effects of HMR(Home Meal Replacement)-Type Medifood on Chronic Metabolic Disorders Including Lipid Metabolism Disorders and Sarcopenia

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.

Study Overview

• Status: Unknown
• Conditions: Lipid Metabolism Disorders; Sarcopenia; Chronic Metabolic Disorder
• Intervention / Treatment: Dietary supplement: HMR(Home meal replacement)-type omega-3-balanced diet

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 Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chungcheongbuk-do
    • Cheongju, Chungcheongbuk-do, Korea, Republic of, 28644
      • Recruiting
      • Chungbuk National University Hospital
      • Contact: Yonghwan Kim, MD; Phone Number: +82-43-269-6060; Email: airsantajin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipids	LDL(Low-density lipoprotein)-cholesterol and HDL(High-density lipoprotein)-cholesterol	4 weeks
triglyceride	Lipids	4 weeks
Muscle mass	SLM (Soft lean mass)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WBC (White blood cell) count	Inflammation	4 weeks
hsCRP (high-sensitivity C-reactive protein)	Inflammation	4 weeks
Balance between omega-3 fatty acids and omega-6 fatty acids	Omega-3 fatty acids to omega-6 fatty acids ratio	4 weeks

Collaborators and Investigators

• Sponsor: Chungbuk National University Hospital
• Investigators: Study Director: Jae Hyun Ahn, Chungbuk National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 19, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: September 13, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (ACTUAL): September 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Disease; Sarcopenia; Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: CBNUH202006021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No