Effect of Kimchi Intake on Body Fat in Overweight Subjects

Obesity Clinical Trial

Official title:

Effect of Kimchi Intake on Body Fat in Overweight Subjects: A Randomized, Double-blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05898802
• Other study ID #: WiKim_2210-037-119
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: June 2023
• Source: World Institute of Kimchi
• Contact: Sung wook Hong, ph.D
• Phone: +82626101760
• Email: swhong[@]wikim.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Kimchi, a traditional Korean food, is prepared through the fermentation of various ingredients. It has been reported that kimchi contains beneficial nutrients from its raw materials, as well as lactic acid bacteria (LAB) and their byproducts produced during fermentation. LAB play an important role in the fermentation process, during which the dominant LAB species emerge and undergo a transition process. Depending on the species and strain of LAB, it has specific functions such as promoting weight loss, reducing inflammation, and lowering cholesterol levels. In this study, the effects of kimchi produced from traditional recipe or kimchi fermented with lactic acid bacteria, which have anti-obesity effects, on body composition changes and metabolic disease index will be investigated in subjects with a BMI of between 23~30kg / m2.

Description:

This is a randomized, double-blind, placebo-controlled clinical trial to investigate the anti-obesity effect of kimchi fermented with the addition of specific lactic acid bacteria.

Two different kimchi, one traditional kimchi and one fermented with a lactic acid bacteria having anti-obesity effect, hereafter starter kimchi, are flash freeze dried, powdered and encapsulated. Specifically, subjects with a BMI of between 23~30kg/m2 take 1,200 mg of traditional kimchi or starter kimchi capsules three times per day before each meal, for a total of 3,600 mg per day. As a control, subjects with a BMI of 23 to 30 kg/m2 take lactose capsules in a similar form and in the same amount. The total study period is 16 weeks of intake of kimchi capsules or placebo capsules, excluding the 2 weeks of preparation period for subject selection. Before and after taking the kimchi capsule or the placebo capsule, the following evaluation criteria of the subject will be measured; DEXA (Dual Energy X-ray Absorptiometry), BMI, Weight, Waist to Hip ratio (WHR), total cholesterol, triglyceride, HDL-C, calculate LDL-C, FFA, HbA1c, glucose, insulin, HOMA-IR, hs-CRP, Adiponectin, Leptin. Also, Changes in gut microbiome composition will be determined by measuring bacterial population levels in stool samples collected before and after taking kimchi capsules or placebo capsules.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: November 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Willing to consent to study participation and to comply with study requirements

• Male and female subjects, 20-65 years of age

• BMI of 23-30 kg/m2

• Those who agreed not to consume Kimchi during the clinical study

Exclusion Criteria:

• Patients with crucial cerebrovascular disease (cerebral infarction, cerebral hemorrhage etc.), or heart failure (angina pectoris, myocardial infarction, heart failure, arrhythmia etc.) or malignancy within 6 months

• Uncontrolled hypertension (Elevated blood pressure (>160/>100))

• Thyroid function test abnormality

• Patients with significantly impaired kidney function: serume creatinine levels =2 times upper limit of normal

• Patients with significantly impaired liver function: ALT or AST=3 times upper limit of normal

• Irregular or occasional gastrointestinal disorders (heartburn, indigestion, etc.)

• Having taken drugs with a known influence on weight in the previous 1 month, such as diet pills, anti-depression drugs, beta-blockers, diuretic, contraceptives, corticosteroids, or female hormones

• Participation in other dietary programmes or services within 3 months

• Participation in other clinical trials within the past 1 month

• Alcohol abuse

• Quitted smoking within 3 months

• Pregnancy or lactation or planning on becoming pregnant

• Have a Kimchi allergy

• Those who are judged unsuitable by the researcher for other reasons

• Taking probiotics within 2 weeks

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Kimchi
Two different kimchi, one traditional kimchi and one fermented with a lactic acid bacteria having anti-obesity effect, hereafter starter kimchi, are flash freeze dried, powdered and encapsulated.
• Placebo
Lactose with kimchi flavor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
World Institute of Kimchi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat mass change in 16-week	Fat mass is measured by DEXA(Dual Energy X-Ray Absorptiometry)	8 weeks, 16 weeks
Secondary	Changes in body mass index (BMI)		8 weeks, 16 weeks
Secondary	Changes in body weight		8 weeks, 16 weeks
Secondary	Changes in waist to hip ratio (WHR)		8 weeks, 16 weeks
Secondary	Changes in Body fat ratio (%)	Body fat ratio (%) will be assessed by DEXA	8 weeks, 16 weeks
Secondary	Changes in Body lean mass (kg)	Body lean mass (kg) will be assessed by DEXA	8 weeks, 16 weeks
Secondary	Changes in serum lipid profile (Total cholesterol, Triglycerides,Low-density lipoprotein,High density lipoprotein)		8 weeks, 16 weeks
Secondary	Changes in free fatty acids (FFA) concentration		8 weeks, 16 weeks
Secondary	Changes in HbA1c		8 weeks, 16 weeks
Secondary	Changes in fasting glucose concentration		8 weeks, 16 weeks
Secondary	Changes in insulin resistance		8 weeks, 16 weeks
Secondary	Changes in HOMA-IR value	HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance	8 weeks, 16 weeks
Secondary	Changes of serum hs-CRP		8 weeks, 16 weeks
Secondary	Changes in adiponection		8 weeks, 16 weeks
Secondary	Changes in leptin		8 weeks, 16 weeks
Secondary	Change of Microbiota composite		8 weeks, 16 weeks