Obesity & OverweightKMGMSNCT07703371
Kodo Millet Porridge and Its Effects on Gut Health and Metabolic Syndrome
A study testing Kodo Millet Porridge Beverage in people with Obesity & Overweight and Metabolic Syndrome, run by JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity & Overweight, Metabolic Syndrome, Gut Dysbiosis
- What is being tested?
- Kodo Millet Porridge Beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2026to 16 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
JSS Medical College, JSS Academy of Higher Education & Research(JSSAHER).
Mysore, Karnataka, 570 015
Prerana Shridhar Bhat, MSc, +91-8762399079, preranabhat@jssuni.edu.in
Dr. Rajesh Kumar Thimmulappa, PhD, +91-9972012892, rajeshkt@jsuni.edu.in
About this study
Official title: Impact of Dietary Fiber-Rich Kodo Millet Porridge Supplementation on Gut Microbiome and Metabolic Syndrome
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.
Read the 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.
- Being tested
- Kodo Millet Porridge Beverage
- 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
- Medical subject headings
- Obesity, Overweight, Metabolic Syndrome, Insulin Resistance, Dyslipidemias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kodo Millet Porridge BeverageDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Kodo Millet Porridge Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, and Week 12
Secondary outcomes (16)
Change in Body Mass Index (BMI)
BMI will be calculated from measured height and weight (kg/m²)
Measured: Baseline, Week 6 and Week 12
Change in Waist-to-Hip Ratio
Waist circumference divided by hip circumference, both measured in centimeters (ratio)
Measured: Baseline, Week 6, and Week 12
Change in Fasting Blood Glucose
Fasting plasma glucose level (mg/dL)
Measured: Baseline, Week 6, and Week 12
Change in Blood Lipid Profile
Total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides (mg/dL)
Measured: Baseline, Week 6, and Week 12
Change in Triglyceride-Glucose (TyG) Index
TyG index calculated using fasting triglycerides and fasting glucose values
Measured: Baseline, Week 6, and Week 12
Change in Blood Pressure
Systolic and diastolic blood pressure (mmHg)
Measured: 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)
Measured: Baseline, Week 6, and Week 12
Change in Glycated Hemoglobin (HbA1c)
HbA1c measured in serum (%)
Measured: Baseline, Week 6, and Week 12
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Serum hs-CRP concentration (mg/L)
Measured: 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)
Measured: 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)
Measured: Baseline, Week 6, and Week 12
Change in Serum Hemoglobin
Hemoglobin concentration measured via standard hematology analyzer (g/dL)
Measured: Baseline, Week 6, and Week 12
Change in Hematocrit
Hematocrit measured via standard hematology analyzer (%)
Measured: Baseline, Week 6, and Week 12
Change in Total Leukocyte Count
Total leukocyte (white blood cell) count measured via standard hematology analyzer (cells/µL)
Measured: Baseline, Week 6, and Week 12
Change in Platelet Count
Platelet count measured via standard hematology analyzer (×10³/µL)
Measured: Baseline, Week 6, and Week 12
Change in Differential Leukocyte Count
Neutrophil, lymphocyte, monocyte, eosinophil, and basophil percentages measured via standard hematology analyzer (%)
Measured: Baseline, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Jun 2026
- Primary completion16 Oct 2026 (estimated)
- Study completion16 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prerana S Bhat, JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH
- Investigators
- Prerana Shridhar Bhat, MSc, Principal investigator, JSS MC,JSS AHER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703371
- Sponsor's protocol ID
- JSSMC/IEC/24102025/24 NCT/2025
- Acronym
- KMGMS
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 37673036Zhang 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.
PubMed 38040541Wu 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.
PubMed 39843443Dall'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.
PubMed 23551992Sola 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.
PubMed 20413122Sobhana 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.
PubMed 33006193Sabovic 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.
PubMed 15187818Lakshmi 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.
PubMed 12602929Dianzhi 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.
PubMed 36071942Alzahrani 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.
PubMed 35565759
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dietary Fiber-Rich Kodo Millet Porridge Supplementation on Gut Microbiome and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07703371
- Acronym / sponsor ID
- KMGMS / JSSMC/IEC/24102025/24 NCT/2025
- Keywords
- Kodo Millet, Dietary Fiber, Gut Microbiome, Short-Chain Fatty Acids, 16S rRNA Sequencing, Metabolic Syndrome, Obesity, Gut Dysbiosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCHUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 16 Oct 2026 (estimated)
- Study completion
- 16 Nov 2026 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Kodo Millet Porridge Intervention | Experimental | Dietary Supplement: Kodo Millet Porridge BeverageParticipants 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kodo Millet Porridge Beverage200 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 | Dietary supplement | Kodo Millet Porridge Intervention |
Primary outcome
Change in Gut Microbiota Composition and Diversity
Time frame: Baseline, and Week 12
Assessment of gut microbiota composition and diversity via 16S rRNA sequencing of stool samples collected at baseline, and week 12
16 secondary outcomes
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
Change in Hematocrit
Time frame: Baseline, Week 6, and Week 12
Change in Total Leukocyte Count
Time frame: Baseline, Week 6, and Week 12
Change in Platelet Count
Time frame: Baseline, Week 6, and Week 12
Change in Differential Leukocyte Count
Time frame: Baseline, Week 6, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 37673036Ni 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.
- Background: PubMed 38040541Zhang 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.
- Background: PubMed 39843443Wu 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.
- Background: PubMed 23551992Dall'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.
- Background: PubMed 20413122Sola 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.
- Background: PubMed 33006193Sobhana 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.
- Background: PubMed 15187818Sabovic 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.
- Background: PubMed 12602929Lakshmi 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.
- BackgroundDianzhi Hou, J. C. (2018). A whole foxtail millet diet reduces blood pressure in subjects with mild hypertension. Journal of Cereal Science.
- Background: PubMed 36071942Chen 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.
- Background: PubMed 35565759Alzahrani 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prerana Shridhar Bhat, MSc principal investigator
JSS MC,JSS AHER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kodo Millet Porridge Beverage in people with Obesity & Overweight and Metabolic Syndrome, run by JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prerana Shridhar Bhat, MSc (+918762399079, preranabhat@jssuni.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gut Microbiota Composition and Diversity (time frame: Baseline, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07703371, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.