NCT Number: NCT07703371
Dietary fiber are components in foods that are not digested by human gastrointestinal enzymes (alpha amylase and alpha glucosidase) but are instead broken down and fermented by gut microbes. The byproducts generated during fermentation in the large intestine, primarily short-chain fatty acids (SCFA), bile acids, indoles, and their derivatives, circulate through the circulatory system to the liver, lungs, brain, adipose tissue, and muscles, where they modulate metabolism (suppress lipogenesis and alleviate insulin resistance) and immune function. Individuals who are overweight or obese frequently exhibit gut dysbiosis, characterized by lower SCFA producing commensals. This condition predisposes them to metabolic disorders such as insulin resistance, dyslipidemia, and hypertension, and contributes to conditions including type 2 diabetes, cardiovascular disease, and metabolic dysfunction-associated steatotic liver disease. Preclinical and clinical research have demonstrated that the consumption of fiber-rich foods maintains or restores gut microbiota health and diminishes the risk of metabolic disorders. Kodo millet (Paspalum scrobiculatum), a small millet, is rich in dietary fiber and we have developed a palatable kodo millet porridge beverage enriched with polyphenols and dietary fiber. The purpose of this study is to examine the effects of consuming Kodo millet porridge beverage as a nutritional supplement for 3 months, on gut microbiome richness (composition and diversity) and metabolic health in overweight or obese people.
Interested in participating?
Request Info20 year–60 year
All sexes
Interventional
Not applicable
Mysore, Karnataka, 570 015, India
Location status: Recruiting
Dr. Rajesh Kumar Thimmulappa, PhD
CONTACT
Prerana Shridhar Bhat, MSc
CONTACT
Prerana Shridhar Bhat, MSc
PRINCIPAL_INVESTIGATOR
This single-center, open-label, pre-post interventional trial enrolls 50 people with a BMI ≥ 25 kg/m² (overweight or obese) and no previous history of cardiovascular, renal, or neurological conditions to consume 200 ml of Kodo millet porridge daily for 12 weeks. The study will examine pre- and post-intervention alterations in individual gut microbiota composition through 16S sequencing, as well as circulatory levels of short-chain fatty acids (SCFA), glycemia, lipidemia, triglyceride-glucose index (a measure of insulin resistance), plasma antioxidant capacity, and markers of oxidative stress and inflammation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
200 ml of standardized Kodo millet porridge enriched with dietary fiber and polyphenols, consumed once daily for 12 weeks (6 days/week). Prepared under controlled conditions and served warm in a disposable paper cup via thermoflask
Time frame: Baseline, and Week 12
Assessment of gut microbiota composition and diversity via 16S rRNA sequencing of stool samples collected at baseline, and week 12
Time frame: Baseline, Week 6 and Week 12
BMI will be calculated from measured height and weight (kg/m²)
Time frame: Baseline, Week 6, and Week 12
Waist circumference divided by hip circumference, both measured in centimeters (ratio)
Time frame: Baseline, Week 6, and Week 12
Fasting plasma glucose level (mg/dL)
Time frame: Baseline, Week 6, and Week 12
Total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides (mg/dL)
Time frame: Baseline, Week 6, and Week 12
TyG index calculated using fasting triglycerides and fasting glucose values
Time frame: Systolic and diastolic blood pressure (mmHg)
Systolic and diastolic blood pressure (mmHg)
Time frame: Baseline, Week 6, and Week 12
Serum lipid peroxidation assessed via C11-BODIPY (or C11 dye-based) fluorescence assay (Relative fluorescence units)
Time frame: Baseline, Week 6, and Week 12
HbA1c measured in serum (%)
Time frame: Baseline, Week 6, and Week 12
Serum hs-CRP concentration (mg/L)
Time frame: Baseline, Week 6, and Week 12
Serum concentrations of interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), interleukin-10 (IL-10), and interferon-gamma (IFN-γ) measured via ELISA (pg/mL)
Time frame: Baseline, Week 6, and Week 12
Serum ZO-1 concentration measured via ELISA, as a marker of intestinal permeability (ng/mL)
Time frame: Baseline, Week 6, and Week 12
Hemoglobin concentration measured via standard hematology analyzer (g/dL)
Time frame: Baseline, Week 6, and Week 12
Hematocrit measured via standard hematology analyzer (%)
Time frame: Baseline, Week 6, and Week 12
Total leukocyte (white blood cell) count measured via standard hematology analyzer (cells/µL)
Time frame: Baseline, Week 6, and Week 12
Platelet count measured via standard hematology analyzer (×10³/µL)
Time frame: Baseline, Week 6, and Week 12
Neutrophil, lymphocyte, monocyte, eosinophil, and basophil percentages measured via standard hematology analyzer (%)
Contact information is provided by the study sponsor or research team.
Dr. Rajesh Kumar Thimmulappa, PhD
CONTACT
Prerana Shridhar Bhat, MSc
CONTACT
JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH
Other
Impact of Dietary Fiber-Rich Kodo Millet Porridge Supplementation on Gut Microbiome and Metabolic Syndrome
Acronym: KMGMS
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