Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07703371

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight, Metabolic Syndrome, Gut Dysbiosis, Insulin Resistance, Dyslipidemia

Full registry 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.

Treatments and study arms

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

Primary outcomes

Change in Gut Microbiota Composition and DiversityBaseline, and Week 12

Assessment of gut microbiota composition and diversity via 16S rRNA sequencing of stool samples collected at baseline, and week 12

Study locations

1 locations were listed when this page was built. The first 40 are shown.

JSS Medical College, JSS Academy of Higher Education & Research(JSSAHER).🇮🇳 Mysore, Karnataka, India

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Prerana Shridhar Bhat, MScContact

Email · Call +91-8762399079

Dr. Rajesh Kumar Thimmulappa, PhDContact

Email · Call +91-9972012892

Prerana Shridhar Bhat, MScPrincipal Investigator