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

NCT07703371 | Recruiting

• 1 other identifier: JSSMC/IEC/24102025/24 NCT/2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity & Overweight; Metabolic Syndrome; Gut Dysbiosis; Insulin Resistance; Dyslipidemia

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (16)

• Change in Body Mass Index (BMI)

  Baseline, Week 6 and Week 12

• Change in Waist-to-Hip Ratio

  Baseline, Week 6, and Week 12

• 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

Study Arms (1)

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

Dietary Supplement: Kodo Millet Porridge Beverage

Interventions

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

Kodo Millet Porridge Intervention

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH: lead

Study Sites (1)

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

Mysore, Karnataka, 570 015, India

RECRUITING

Related Publications (11)

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  PMID: 37673036 BACKGROUND

• 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.

  PMID: 38040541 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.

  PMID: 39843443 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.

  PMID: 23551992 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.

  PMID: 20413122 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Dianzhi Hou, J. C. (2018). A whole foxtail millet diet reduces blood pressure in subjects with mild hypertension. Journal of Cereal Science.

  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.

  PMID: 36071942 BACKGROUND

• 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.

  PMID: 35565759 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight; Metabolic Syndrome; Insulin Resistance; Dyslipidemias; Inflammation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Lipid Metabolism Disorders; Pathologic Processes

Study Officials

• Prerana Shridhar Bhat, MSc

  JSS MC,JSS AHER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prerana Shridhar Bhat, MSc

CONTACT

+918762399079; preranabhat@jssuni.edu.in

Dr. Rajesh Kumar Thimmulappa, PhD

CONTACT

+91-9972012892; rajeshkt@jssuni.edu.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Scholar and Principal Investigator, Department of Biochemistry

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 14, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): November 16, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

IN (1)