The Impact of Resistant Starch Foods on Metabolic Health and Gut Microbiome

Effect of resistant starch diet product on metabolic parameters and gut microbiome, a prospective, double-blind, randomized study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011082

Enrollment

Registered

2025-10-30

Start date

2024-03-15

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

None listed

Interventions

Dietary Supplement : The resistant starch (RS) group consumed RS-enriched products (cereal, energy bars, and misugaru) once daily, six times per week, for eight weeks.The control group consumed iso-ca

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Women aged 40 years or older, Having two or more risk factors for metabolic syndrome (abdominal obesity, fasting glucose =100 mg/dL, triglycerides =150 mg/dL, low HDL-C, or blood pressure =130/85 mmHg), Provided written informed consent after being fully informed of the study purpose and procedures

Exclusion criteria

Exclusion criteria: AST or ALT > 120 mg/dL Serum creatinine > 2.0 mg/dL Abnormal thyroid function: TSH > 10 µIU/mL or TSH 160/100 mmHg) or uncontrolled diabetes (fasting glucose > 180 mg/dL, or recent escalation of medication within 3 months) History of malignancy within the past 5 years Esophageal motility disorders (e.g., achalasia, stricture) or history of gastrectomy causing malabsorption Uncontrolled chronic diseases (chronic liver disease, alcoholism, primary hyperparathyroidism, Cushing’s syndrome, inflammatory bowel disease, etc.) Current use of immunosuppressants or corticosteroids Clinically significant allergic disease or allergy to study food components (resistant starch) Requirement for continuous use of antibiotics or probiotics during the study period Psychiatric disorders (depression, anxiety, sleep disorders) under medication Participation in another clinical trial within the past month, or planning to participate in another trial during the study; relocation or frequent travel expected Considered inappropriate for the study by investigators

Design outcomes

Primary

Measure	Time frame
Change in metabolic syndrome indicators (waist circumference, fasting glucose, blood pressure, triglycerides, HDL cholesterol);Change in gut microbiome (composition and diversity)	—

Secondary

Measure	Time frame
Change in urinary organic acids;Change in fecal calprotectin;Change in heart rate variability (HRV)	—

Countries

Korea, Republic of

Contacts

Public ContactNam-Seok Joo

Ajou University

jchcmc@hanmail.net+82-31-219-5218

Outcome results