Dyslipidemia, Gut Dysbiosis, Insulin Resistance, Metabolic Syndrome, Obesity & Overweight
Conditions
Keywords
Kodo Millet, Dietary Fiber, Gut Microbiome, Short-Chain Fatty Acids, 16S rRNA Sequencing, Metabolic Syndrome, Obesity, Gut Dysbiosis, Dyslipidemia, Glycemia, Prebiotic, Small Millet, Porridge, Antioxidant, Inflammation
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTKodo Millet Porridge Beverage
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
Sponsors
JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All 50 enrolled participants receive the same intervention - 200 ml of Kodo millet porridge daily for 12 weeks. There is no comparator or control arm. Outcomes are assessed using a pre-post (before and after) design.
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 20-60 years. * Willingness to provide informed consent. * Willingness to consume Kodo millet porridge daily for 12 weeks. * No planned changes in diet or physical activity during the study. * Overweight or obese (BMI ≥ 25 kg/m²), placing them at risk for metabolic disorders.
Exclusion criteria
* Known allergies to millet or any porridge ingredients. * Individuals who are taking on-counter dietary fiber and probiotics supplements * History of any chronic gastrointestinal diseases (e.g., IBD, gastritis, irritable bowel syndrome). * Pregnant or lactating women. * Antibiotic use in last 3 months. * Alcohol abuse, more than 2 drink per day * Presence and usage of medications for any serious chronic illnesses, including uncontrolled diabetes (HbA1c \> 9), cardiovascular disease (aldosterone antagonists, alpha blockers, alpha-beta blockers, anticoagulants, antiplatelets, angiotensin-converting enzyme inhibitors, angiotensin 2 receptor blockers, beta blockers, calcium channel blockers, diuretics, digoxin) , renal disease, neurological or mental disorders, coagulation disorders, and cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gut Microbiota Composition and Diversity | Baseline, and Week 12 | Assessment of gut microbiota composition and diversity via 16S rRNA sequencing of stool samples collected at baseline, and week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | Baseline, Week 6 and Week 12 | BMI will be calculated from measured height and weight (kg/m²) |
| Change in Waist-to-Hip Ratio | Baseline, Week 6, and Week 12 | Waist circumference divided by hip circumference, both measured in centimeters (ratio) |
| Change in Fasting Blood Glucose | Baseline, Week 6, and Week 12 | Fasting plasma glucose level (mg/dL) |
| Change in Blood Lipid Profile | Baseline, Week 6, and Week 12 | Total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides (mg/dL) |
| Change in Triglyceride-Glucose (TyG) Index | Baseline, Week 6, and Week 12 | TyG index calculated using fasting triglycerides and fasting glucose values |
| Change in Blood Pressure | Systolic and diastolic blood pressure (mmHg) | Systolic and diastolic blood pressure (mmHg) |
| Change in Serum Antioxidant Status | Baseline, Week 6, and Week 12 | Serum lipid peroxidation assessed via C11-BODIPY (or C11 dye-based) fluorescence assay (Relative fluorescence units) |
| Change in Glycated Hemoglobin (HbA1c) | Baseline, Week 6, and Week 12 | HbA1c measured in serum (%) |
| Change in High-Sensitivity C-Reactive Protein (hs-CRP) | Baseline, Week 6, and Week 12 | Serum hs-CRP concentration (mg/L) |
| Change in Serum Inflammatory Cytokines (IL-6, TNF-alpha, IL-10, IFN-gamma) | 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) |
| Change in Serum Zonulin/ZO-1 (Tight Junction Protein) Levels | Baseline, Week 6, and Week 12 | Serum ZO-1 concentration measured via ELISA, as a marker of intestinal permeability (ng/mL) |
| Change in Serum Hemoglobin | Baseline, Week 6, and Week 12 | Hemoglobin concentration measured via standard hematology analyzer (g/dL) |
| Change in Hematocrit | Baseline, Week 6, and Week 12 | Hematocrit measured via standard hematology analyzer (%) |
| Change in Total Leukocyte Count | Baseline, Week 6, and Week 12 | Total leukocyte (white blood cell) count measured via standard hematology analyzer (cells/µL) |
| Change in Platelet Count | Baseline, Week 6, and Week 12 | Platelet count measured via standard hematology analyzer (×10³/µL) |
| Change in Differential Leukocyte Count | Baseline, Week 6, and Week 12 | Neutrophil, lymphocyte, monocyte, eosinophil, and basophil percentages measured via standard hematology analyzer (%) |
Countries
India
Contacts
CONTACTPrerana Shridhar Bhat, MSc
CONTACTDr. Rajesh Kumar Thimmulappa, PhD
PRINCIPAL_INVESTIGATORPrerana Shridhar Bhat, MSc
JSS MC,JSS AHER
Outcome results
None listed