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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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

Первичные конечные точки

• Change in Gut Microbiota Composition and Diversity [Срок оценки: Baseline, and Week 12]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Индия · 1 центр

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

Публикации

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Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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