Kodo Millet Porridge and Its Effects on Gut Health and Metabolic Syndrome

Official title

Impact of Dietary Fiber-Rich Kodo Millet Porridge Supplementation on Gut Microbiome and Metabolic Syndrome

Overview

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 supplement Kodo 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

Primary outcome measures

• Change in Gut Microbiota Composition and Diversity [Time frame: Baseline, and Week 12]

Secondary outcome measures (12)

• Change in Body Mass Index (BMI) [Time frame: Baseline, Week 6 and Week 12]
• Change in Waist-to-Hip Ratio [Time frame: Baseline, Week 6, and Week 12]
• Change in Fasting Blood Glucose [Time frame: Baseline, Week 6, and Week 12]
• Change in Blood Lipid Profile [Time frame: Baseline, Week 6, and Week 12]
• Change in Triglyceride-Glucose (TyG) Index [Time frame: Baseline, Week 6, and Week 12]
• Change in Blood Pressure [Time frame: Systolic and diastolic blood pressure (mmHg)]
• Change in Serum Antioxidant Status [Time frame: Baseline, Week 6, and Week 12]
• Change in Glycated Hemoglobin (HbA1c) [Time frame: Baseline, Week 6, and Week 12]
• Change in High-Sensitivity C-Reactive Protein (hs-CRP) [Time frame: Baseline, Week 6, and Week 12]
• Change in Serum Inflammatory Cytokines (IL-6, TNF-alpha, IL-10, IFN-gamma) [Time frame: Baseline, Week 6, and Week 12]
• Change in Serum Zonulin/ZO-1 (Tight Junction Protein) Levels [Time frame: Baseline, Week 6, and Week 12]
• Change in Serum Hemoglobin [Time frame: Baseline, Week 6, and Week 12]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

India · 1 center

• JSS Medical College, JSS Academy of Higher Education & Research(JSSAHER). — Mysore

Publications

• 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. PMID 37673036
• Zhang X, Irajizad E, Hoffman KL, Fahrmann JF, Li F, Seo YD, Browman GJ, Dennison JB, Vykoukal J, Luna PN, Siu W, Wu R, Murage E, Ajami NJ, McQuade JL, Wargo JA, Long JP, Do KA, Lampe JW, Basen-Engquist KM, Okhuysen PC, Kopetz S, Hanash SM, Petrosino JF, Scheet P, Daniel CR. Modulating a prebiotic food source influences inflammation and immune-regulating gut microbes and metabolites: insights from PMID 38040541
• 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. PMID 39843443
• 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. PMID 23551992
• 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( PMID 20413122
• Sobhana PP, Kandlakunta B, Nagaraju R, Thappatla D, Epparapalli S, Vemula SR, Gavaravarapu SRM, Korrapati D. Human clinical trial to assess the effect of consumption of multigrain Indian bread on glycemic regulation in type 2 diabetic participants. J Food Biochem. 2020 Nov;44(11):e13465. doi: 10.1111/jfbc.13465. Epub 2020 Oct 1. PMID 33006193
• Sabovic M, Lavre S, Keber I. Supplementation of wheat fibre can improve risk profile in patients with dysmetabolic cardiovascular syndrome. Eur J Cardiovasc Prev Rehabil. 2004 Apr;11(2):144-8. doi: 10.1097/01.hjr.0000124213.21584.75. PMID 15187818
• Lakshmi Kumari P, Sumathi S. Effect of consumption of finger millet on hyperglycemia in non-insulin dependent diabetes mellitus (NIDDM) subjects. Plant Foods Hum Nutr. 2002 Fall;57(3-4):205-13. doi: 10.1023/a:1021805028738. PMID 12602929

Identifiers

NCT: NCT07703371 · JSSMC/IEC/24102025/24 NCT/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗