KMGMS
Impact of Dietary Fiber-Rich Kodo Millet Porridge Supplementation on Gut Microbiome and Metabolic Syndrome
Sponsor study identifier
interventional
50
1 country
1
Study Start
June 1, 2026
Actual (reported)Primary Completion
October 16, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 16, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 16, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2026
Actual (reported)June 30, 2026
Actual (reported)July 14, 2026
Actual (reported)October 16, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 16, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Change in Body Mass Index (BMI)
Baseline, Week 6 and Week 12
Change in Waist-to-Hip Ratio
Baseline, Week 6, and Week 12
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
JSS Medical College, JSS Academy of Higher Education & Research(JSSAHER).
Mysore, Karnataka, 570 015, India
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.
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 the BE GONE trial. EBioMedicine. 2023 Dec;98:104873. doi: 10.1016/j.ebiom.2023.104873. Epub 2023 Nov 30.
Prerana Shridhar Bhat, MSc
JSS MC,JSS AHER
First Submitted
June 30, 2026
First Posted
July 14, 2026
Study Start
June 1, 2026
Actual (reported)Change in Fasting Blood Glucose
Baseline, Week 6, and Week 12
Change in Blood Lipid Profile
Baseline, Week 6, and Week 12
Change in Triglyceride-Glucose (TyG) Index
Baseline, Week 6, and Week 12
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
Dianzhi Hou, J. C. (2018). A whole foxtail millet diet reduces blood pressure in subjects with mild hypertension. Journal of Cereal Science.
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.
Alzahrani NS, Alshammari GM, El-Ansary A, Yagoub AEA, Amina M, Saleh A, Yahya MA. Anti-Hyperlipidemia, Hypoglycemic, and Hepatoprotective Impacts of Pearl Millet (Pennisetum glaucum L.) Grains and Their Ethanol Extract on Rats Fed a High-Fat Diet. Nutrients. 2022 Apr 25;14(9):1791. doi: 10.3390/nu14091791.
Primary Completion
October 16, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 16, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 14, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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