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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kodo Millet Porridge Intervention | Experimental | Participants consume 200 ml of Kodo millet porridge (5% Kodo millet by weight) daily for 12 weeks, 6 days per week, served at 10-11 AM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kodo Millet Porridge Beverage | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gut Microbiota Composition and Diversity | Assessment of gut microbiota composition and diversity via 16S rRNA sequencing of stool samples collected at baseline, and week 12 | Baseline, and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index (BMI) | BMI will be calculated from measured height and weight (kg/m²) | Baseline, Week 6 and Week 12 |
| Change in Waist-to-Hip Ratio | Waist circumference divided by hip circumference, both measured in centimeters (ratio) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prerana Shridhar Bhat, MSc | Contact | +918762399079 | preranabhat@jssuni.edu.in | |
| Dr. Rajesh Kumar Thimmulappa, PhD | Contact | +91-9972012892 | rajeshkt@jssuni.edu.in |
| Name | Affiliation | Role |
|---|---|---|
| Prerana Shridhar Bhat, MSc | JSS MC,JSS AHER | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JSS Medical College, JSS Academy of Higher Education & Research(JSSAHER). | Recruiting | Mysore | Karnataka | 570 015 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37673036 | Background | Ni Y, Qian L, Siliceo SL, Long X, Nychas E, Liu Y, Ismaiah MJ, Leung H, Zhang L, Gao Q, Wu Q, Zhang Y, Jia X, Liu S, Yuan R, Zhou L, Wang X, Li Q, Zhao Y, El-Nezami H, Xu A, Xu G, Li H, Panagiotou G, Jia W. Resistant starch decreases intrahepatic triglycerides in patients with NAFLD via gut microbiome alterations. Cell Metab. 2023 Sep 5;35(9):1530-1547.e8. doi: 10.1016/j.cmet.2023.08.002. | |
| 38040541 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| D050171 | Dyslipidemias |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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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.
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|
| Baseline, Week 6, and Week 12 |
| Change in Fasting Blood Glucose | Fasting plasma glucose level (mg/dL) | Baseline, Week 6, and Week 12 |
| Change in Blood Lipid Profile | Total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides (mg/dL) | Baseline, Week 6, and Week 12 |
| Change in Triglyceride-Glucose (TyG) Index | TyG index calculated using fasting triglycerides and fasting glucose values | Baseline, Week 6, and Week 12 |
| Change in Blood Pressure | Systolic and diastolic blood pressure (mmHg) | Systolic and diastolic blood pressure (mmHg) |
| Change in Serum Antioxidant Status | Serum lipid peroxidation assessed via C11-BODIPY (or C11 dye-based) fluorescence assay (Relative fluorescence units) | Baseline, Week 6, and Week 12 |
| Change in Glycated Hemoglobin (HbA1c) | HbA1c measured in serum (%) | Baseline, Week 6, and Week 12 |
| Change in High-Sensitivity C-Reactive Protein (hs-CRP) | Serum hs-CRP concentration (mg/L) | Baseline, Week 6, and Week 12 |
| Change in Serum Inflammatory Cytokines (IL-6, TNF-alpha, IL-10, IFN-gamma) | 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) | Baseline, Week 6, and Week 12 |
| Change in Serum Zonulin/ZO-1 (Tight Junction Protein) Levels | Serum ZO-1 concentration measured via ELISA, as a marker of intestinal permeability (ng/mL) | Baseline, Week 6, and Week 12 |
| Change in Serum Hemoglobin | Hemoglobin concentration measured via standard hematology analyzer (g/dL) | Baseline, Week 6, and Week 12 |
| Change in Hematocrit | Hematocrit measured via standard hematology analyzer (%) | Baseline, Week 6, and Week 12 |
| Change in Total Leukocyte Count | Total leukocyte (white blood cell) count measured via standard hematology analyzer (cells/µL) | Baseline, Week 6, and Week 12 |
| Change in Platelet Count | Platelet count measured via standard hematology analyzer (×10³/µL) | Baseline, Week 6, and Week 12 |
| Change in Differential Leukocyte Count | Neutrophil, lymphocyte, monocyte, eosinophil, and basophil percentages measured via standard hematology analyzer (%) | Baseline, Week 6, and Week 12 |
| Background |
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| 39843443 | Background | Wu X, Tjahyo AS, Volchanskaya VSB, Wong LH, Lai X, Yong YN, Osman F, Tay SL, Govindharajulu P, Ponnalagu S, Tso R, Teo HS, Khoo K, Fan H, Goh CC, Yap CPL, Leow MK, Henry CJ, Haldar S, Lim KJ. A legume-enriched diet improves metabolic health in prediabetes mediated through gut microbiome: a randomized controlled trial. Nat Commun. 2025 Jan 22;16(1):942. doi: 10.1038/s41467-025-56084-6. |
| 23551992 | Background | Dall'Alba V, Silva FM, Antonio JP, Steemburgo T, Royer CP, Almeida JC, Gross JL, Azevedo MJ. Improvement of the metabolic syndrome profile by soluble fibre - guar gum - in patients with type 2 diabetes: a randomised clinical trial. Br J Nutr. 2013 Nov 14;110(9):1601-10. doi: 10.1017/S0007114513001025. Epub 2013 Apr 3. |
| 20413122 | Background | Sola R, Bruckert E, Valls RM, Narejos S, Luque X, Castro-Cabezas M, Domenech G, Torres F, Heras M, Farres X, Vaquer JV, Martinez JM, Almaraz MC, Anguera A. Soluble fibre (Plantago ovata husk) reduces plasma low-density lipoprotein (LDL) cholesterol, triglycerides, insulin, oxidised LDL and systolic blood pressure in hypercholesterolaemic patients: A randomised trial. Atherosclerosis. 2010 Aug;211(2):630-7. doi: 10.1016/j.atherosclerosis.2010.03.010. Epub 2010 Mar 17. |
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| Background | Dianzhi Hou, J. C. (2018). A whole foxtail millet diet reduces blood pressure in subjects with mild hypertension. Journal of Cereal Science. |
| 36071942 | Background | Chen Y, Zhang R, Xu J, Ren Q. Alteration of intestinal microflora by the intake of millet porridge improves gastrointestinal motility. Front Nutr. 2022 Aug 22;9:965687. doi: 10.3389/fnut.2022.965687. eCollection 2022. |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |
| D010335 | Pathologic Processes |