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

NCT04552574 | Unknown DMC

• 1 other identifier: CBNUH202006021
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Metabolic Disorder; Lipid Metabolism Disorders; Sarcopenia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• WBC (White blood cell) count

  4 weeks

• hsCRP (high-sensitivity C-reactive protein)

  4 weeks

• Balance between omega-3 fatty acids and omega-6 fatty acids

  4 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

No intervention for 4 weeks.

Interventions

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

Intervention group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chungbuk National University Hospital: lead

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 34202690 DERIVED

MeSH Terms

Conditions

Lipid Metabolism Disorders; Sarcopenia

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Jae Hyun Ahn

  Chungbuk National University Hospital

  STUDY DIRECTOR

Central Study Contacts

Yonghwan Kim, MD

CONTACT

82-43-269-6060; airsantajin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: September 17, 2020
• Study Start: August 19, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)