Effects of a Lifestyle Medicine-Based Intervention in Adults with Metabolic Syndrome

Effects of a Lifestyle Medicine-Based Integrated Oral-Gut Health Program on Metabolic Markers in Adults with Metabolic Syndrome: A Non-Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011633

Enrollment

100

Registered

2026-02-23

Start date

2026-03-02

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Lifestyle medicine education program) : This study evaluates the effects of a lifestyle medicine-based integrated oral-gut health intervention program. [Intervention Group] Non-surgical period

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults aged 30 years or older meeting all of the following criteria: 1. Metabolic Syndrome: Meeting 3 or more of the following 5 criteria based on Modified NCEP-ATP III Asia-Pacific criteria: Waist circumference: =90cm for men, =85cm for women Triglycerides (TG): =150 mg/dL or on medication HDL-cholesterol: <40 mg/dL for men, <50 mg/dL for women, or on medication Blood pressure: Systolic =130 mmHg or diastolic =85 mmHg, or on antihypertensive medication Fasting plasma glucose: =100 mg/dL or on antidiabetic medication 2. Periodontal Disease: Presence of periodontal pockets with probing depth (PD) =4mm or clinical attachment loss (CAL) in 2 or more quadrants (with =20 remaining teeth) 3. Functional Constipation: Meeting Rome IV diagnostic criteria with 2 or more of the following symptoms during the last 3 months: Straining during =25% of defecations Lumpy or hard stools (Bristol Stool Scale types 1-2) in =25% of defecations Sensation of incomplete evacuation in =25% of defecations Sensation of anorectal obstruction/blockage in =25% of defecations Manual maneuvers to facilitate defecation in =25% of defecations Fewer than 3 spontaneous bowel movements per week 4. Voluntary willingness to participate in the study and ability to provide written informed consent 5. Able to comply with program participation and examination schedules during the study period

Exclusion criteria

Exclusion criteria: Individuals meeting one or more of the following criteria will be excluded: 1. Uncontrolled diabetes (HbA1c > 9.0%) 2. Systemic antibiotic or steroid use within the past 3 months 3. Pregnant or lactating women 4. Known allergy to components of the probiotic product (milk, soy) 5. Severe cognitive impairment or mental illness that prevents program participation or questionnaire completion 6. Periodontal surgery (gingivectomy, periodontal flap surgery, etc.) within the past 6 months 7. Serious systemic diseases: Uncontrolled cardiovascular disease (myocardial infarction, stroke, or unstable angina within the past 6 months) Active cancer or undergoing cancer treatment Severe liver disease (cirrhosis, liver failure) Severe kidney disease (chronic kidney disease stage 4-5, on dialysis) Taking immunosuppressants or having immunodeficiency disorders 8. Participation in another clinical study within the past 3 months 9. Any condition deemed inappropriate for study participation by the principal investigator

Design outcomes

Primary

Measure	Time frame
Change in 7 oral pathogenic bacteria levels: Quantitative changes in Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, Campylobacter rectus, Fusobacterium nucleatum, and Streptococcus mutans measured by quantitative polymerase chain reaction (qPCR) analysis of gargle samples from baseline to 8 weeks (Log2 Fold Change);Change in Gut Microbiome Index (GMI): Change in GMI from baseline to 8 weeks, measured by 16S rRNA gene sequencing analysis of fecal samples. GMI is a gut microbiome health assessment index developed based on meta-analysis of Korean and global population datasets.;Change in Metabolic Syndrome Severity Z-score (MetS-Z Score): Change from baseline to 8 weeks in continuous severity score calculated by confirmatory factor analysis integrating 5 metabolic components (waist circumference, systolic blood pressure, fasting plasma glucose, HDL-cholesterol, triglycerides). Gender- and age-specific formulas based on Korean National Health and Nutrition Examination Survey data applied.	—

Measure

Time frame

Change in 7 oral pathogenic bacteria levels: Quantitative changes in Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, Campylobacter rectus, Fusobacterium nucleatum, and Streptococcus mutans measured by quantitative polymerase chain reaction (qPCR) analysis of gargle samples from baseline to 8 weeks (Log2 Fold Change);Change in Gut Microbiome Index (GMI): Change in GMI from baseline to 8 weeks, measured by 16S rRNA gene sequencing analysis of fecal samples. GMI is a gut microbiome health assessment index developed based on meta-analysis of Korean and global population datasets.;Change in Metabolic Syndrome Severity Z-score (MetS-Z Score): Change from baseline to 8 weeks in continuous severity score calculated by confirmatory factor analysis integrating 5 metabolic components (waist circumference, systolic blood pressure, fasting plasma glucose, HDL-cholesterol, triglycerides). Gender- and age-specific formulas based on Korean National Health and Nutrition Examination Survey data applied.

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Secondary

Measure	Time frame
Change in individual metabolic parameters: Changes from baseline to 8 weeks in waist circumference (cm), systolic/diastolic blood pressure (mmHg), fasting plasma glucose (mg/dL), triglycerides (mg/dL), and HDL-cholesterol (mg/dL)	—

Countries

Korea, Republic of

Contacts

Public ContactMu Yeol Cho

Apple Tree Medical Foundation

whanduf@appleden.com+82-70-4601-5479

Outcome results