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A Pilot Study to Evaluate Gut Microbiota-Based Glycemic Responses to Meals

A Pilot Study to Develop a Microbiome-Based Model for Predicting Dietary Responsiveness

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010920
Enrollment
45
Registered
2025-08-19
Start date
2025-08-12
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

None listed

Interventions

Others(Carbohydrate meal) : - This is a single-arm intervention study, in which all participants are assigned to the same intervention group without a control group and receive the intervention. - All

Sponsors

Korea Food Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Adults with a BMI between 18.5 and less than 35 kg/m² (ranging from normal weight to the pre–severe obesity stage) - Able to provide blood, urine, stool, and saliva samples - No objection to wearing a continuous glucose monitoring device for more than 10 days on a soft, non-muscular area on the back of either upper arm

Exclusion criteria

Exclusion criteria: - Women who are pregnant or breastfeeding - Individuals with specific food allergies - Individuals with skin inflammation or dermatological conditions - Individuals scheduled to undergo medical procedures involving strong magnetic or electromagnetic radiation during the study period (e.g., X-ray, MRI, CT scan) - Patients with glucose–galactose malabsorption or diabetes insipidus - Patients with hypersensitivity or a history of allergy to Sunset Yellow FCF (Yellow No. 5) or Tartrazine (Yellow No. 4) - Individuals who have taken antibiotics within the past 3 months - Individuals with high-risk drinking habits or diagnosed with alcohol dependence within the past 3 months - Individuals with a body weight change of =10% within the past 3 months, or currently following a controlled diet for weight management - Individuals who have participated in another clinical trial within the past 3 months involving administration of an investigational product or dietary intervention - Individuals requiring dietary restrictions due to diseases such as diabetes, hypertension, cardiovascular disease, kidney disease, gastrointestinal disease, fatty liver, or thyroid disorders - Individuals requiring continuous blood glucose management or currently receiving pharmacological treatment such as antidiabetic drugs or insulin - Individuals taking medications that may affect body weight - Individuals presenting with acute illness (e.g., fever) at the set-up visit or baseline visit (study start date) - Individuals with a history of major gastrointestinal surgery (except cholecystectomy or appendectomy) or bowel resection within the past 6 months - Individuals with uncontrolled active gastrointestinal diseases or disorders - Individuals with a history of cardiovascular diseases (e.g., heart failure, myocardial infarction, stroke), renal diseases (e.g., chronic kidney failure, nephrotic syndrome), pulmonary diseases (e.g., asthma, chronic obstructive pulmonary disease), or hepatitis B or C - Individuals with a history of cancer, except for localized resected squamous cell carcinoma or basal cell carcinoma of the skin

Design outcomes

Primary

MeasureTime frame
Postprandial glucose response following the test meal

Secondary

MeasureTime frame
Gut microbiome composition

Countries

Korea, Republic of

Contacts

Public ContactSangwon Chung

Korea Food Research Institute

schung@kfri.re.kr+82-63-219-9075

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026