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- Ensayo clínico NCT07688694
Development of Anti-Diabetic Nutraceuticals From Legume Seed Coats
Evaluation of Boiled Water Extracts of Legumes Seed Coats for Alpha Amylase and Alpha Glucosidase Activity: Formulation of Anti- Diabetic Nutraceuticals
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Type 2 diabetes mellitus (T2DM) is one of the leading metabolic disorders worldwide and is associated with increased morbidity and mortality. Elevated postprandial blood glucose levels are recognized as an important risk factor for the development and exacerbation of T2DM and its macro- and micro-vascular complications. The acute glucose fluctuations induce oxidative stress and systemic inflammation and fastens the disease progression. Most oral anti-diabetic medications (metformin, sulfonylureas, thiazolidinediones) lower basal blood glucose levels; nevertheless, for effective long-term glycemic control, postprandial hyperglycemia must also be effectively managed.
Alpha-glucosidase inhibitors (AGIs) are a unique group of oral anti-diabetic medications that help lower post-prandial glucose spikes. They work by blocking the alpha-glucosidase enzyme in the intestine, which normally breaks down complex sugars into glucose for absorption. Currently, a few FDA-approved AGIs-such as acarbose, miglitol, and voglibose-are used to manage type 2 diabetes (T2DM). These drugs have been shown to improve blood sugar control and reduce risks of heart disease. Clinical trials suggest that the efficacy of acarbose to manage blood sugar is comparable to metformin, and the combination of both drugs is even more effective. However, long-term use of acarbose is often limited by digestive side effects. This highlights the need for safer, more selective, and better-tolerated AGIs.
Legume seeds are rich in polyphenols, flavonoids, and dietary fiber, which are known to inhibit alpha-amylase and alpha-glucosidase activity. After screening commonly consumed legumes, our laboratory identified boiled water extracts of certain seed coats with strong alpha-glucosidase inhibition, as well as antioxidant and anti-inflammatory properties. We have developed a palatable soup using these extracts.
This open-label, pre-post clinical trial will test whether daily consumption of the soup improves blood sugar control in individuals at high risk, including those with metabolic syndrome and type 2 diabetes mellitus (T2DM). The study will also include healthy volunteers. Participants will consume the soup daily for one month. Primary outcomes will include changes in fasting blood glucose, HbA1c, and postprandial glucose levels, assessed at predefined time points. Secondary outcomes will examine changes in lipid profile (dyslipidemia), biomarkers of oxidative stress, and markers of systemic inflammation. This study builds on prior laboratory findings and seeks to translate them into a practical, palatable dietary intervention with potential relevance for the prevention and management of hyperglycemia and associated metabolic disorders.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Karnataka
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Mysore, Karnataka, India, 570015
- JSS Medical College
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
i. Healthy volunteers aged 20 to <60 years. ii. Individuals with one or more of the following risk factors: BMI >25 kg/m², systolic blood pressure (SBP) >130 mmHg, dyslipidemia, or HbA1c between 5.7-6.4% (prediabetes range).
iii. Adults diagnosed with type 2 diabetes mellitus (T2DM).
Exclusion Criteria:
i. History of gastrointestinal diseases. ii. Use of antibiotics within the past 3 months. iii. Pregnant or lactating women. iv. Individuals diagnosed with cardiovascular disease, chronic kidney disease, cancer, liver disease, or autoimmune disorders.
v. Current use of alpha-glucosidase inhibitor medications.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Open-label Pre-post Trial of Legume Seed Coat Soup
Participants will consume 200 ml of legume seed coat soup daily for four weeks, excluding Sundays, with delivery scheduled between 10:00 and 12:00 noon.
Anthropometric measurements and blood samples will be collected at baseline and after the four-week intervention, while capillary blood glucose will be assessed using a glucometer at baseline, two weeks, and four weeks.
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The pre-processed seed coats of legumes (Vigna mungo or Macrotyloma uniflorum) are boiled to obtain extracts, combined with varying amounts of cooked cotyledons, and seasoned with salt and spices.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from baseline in Fasting blood glucose and HbA1c at 4 weeks
Periodo de tiempo: Baseline and 4th week
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Fasting blood glucose and plasma HbA1c measured at clinical biochemistry diagnostic laboratory.
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Baseline and 4th week
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Change from baseline in capillary blood glucose levels after meal at 2 and 4 week
Periodo de tiempo: Baseline, 2nd week and 4th week
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Capillary blood glucose levels at baseline, 30 min, 60 min, 90 min and 120 min after a meal by glucometer
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Baseline, 2nd week and 4th week
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in Total cholesterol, triglycerides, LDL, HDL at 4 weeks
Periodo de tiempo: Baseline and 4th week
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Lipid profile (total cholesterol, triglycerides, LDL-C, and HDL-C) assessment before and after the intervention at the Clinical Biochemistry Diagnostic Laboratory.
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Baseline and 4th week
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Change from baseline in circulatory markers of oxidative stress at 4 week
Periodo de tiempo: Baseline and 4th week
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Serum total antioxidant capacity (TAC) and serum free thiols measurement using spectrofluorometry and spectrophotometry.
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Baseline and 4th week
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Change from baseline in circulatory markers of inflammation at 4 weeks
Periodo de tiempo: Baseline and 4th week
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Serum cytokines measurement by immunoassay
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Baseline and 4th week
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Change from baseline in serum creatinine at 4 weeks
Periodo de tiempo: Baseline and 4th week
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Serum creatinine levels measurement at clinical biochemistry diagnostic laboratory
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Baseline and 4th week
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Change from baseline in Systolic blood pressure & Diastolic Blood pressure at 4 weeks
Periodo de tiempo: Baseline and 4th week
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Blood pressure measurement using a digital blood pressure monitor
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Baseline and 4th week
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Change from baseline in bodyweight at 4 weeks
Periodo de tiempo: Baseline and 4th week
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Body weight measurement using adigital scale
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Baseline and 4th week
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Rajesh K Thimmulappa, JSS Academy of Higher Education and Research
Publicaciones y enlaces útiles
Publicaciones Generales
- Xiao J, Kai G, Yamamoto K, Chen X. Advance in dietary polyphenols as alpha-glucosidases inhibitors: a review on structure-activity relationship aspect. Crit Rev Food Sci Nutr. 2013;53(8):818-36. doi: 10.1080/10408398.2011.561379.
- Rosenstock J, Brown A, Fischer J, Jain A, Littlejohn T, Nadeau D, Sussman A, Taylor T, Krol A, Magner J. Efficacy and safety of acarbose in metformin-treated patients with type 2 diabetes. Diabetes Care. 1998 Dec;21(12):2050-5. doi: 10.2337/diacare.21.12.2050.
- Chiasson JL, Josse RG, Gomis R, Hanefeld M, Karasik A, Laakso M; STOP-NIDDM Trial Research Group. Acarbose treatment and the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance: the STOP-NIDDM trial. JAMA. 2003 Jul 23;290(4):486-94. doi: 10.1001/jama.290.4.486.
- van de Laar FA, Lucassen PL, Akkermans RP, van de Lisdonk EH, Rutten GE, van Weel C. Alpha-glucosidase inhibitors for patients with type 2 diabetes: results from a Cochrane systematic review and meta-analysis. Diabetes Care. 2005 Jan;28(1):154-63. doi: 10.2337/diacare.28.1.154.
- Preiss D, Lloyd SM, Ford I, McMurray JJ, Holman RR, Welsh P, Fisher M, Packard CJ, Sattar N. Metformin for non-diabetic patients with coronary heart disease (the CAMERA study): a randomised controlled trial. Lancet Diabetes Endocrinol. 2014 Feb;2(2):116-24. doi: 10.1016/S2213-8587(13)70152-9. Epub 2013 Nov 7.
- Moelands SV, Lucassen PL, Akkermans RP, De Grauw WJ, Van de Laar FA. Alpha-glucosidase inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus. Cochrane Database Syst Rev. 2018 Dec 28;12(12):CD005061. doi: 10.1002/14651858.CD005061.pub3.
- Hinnen DA. Therapeutic Options for the Management of Postprandial Glucose in Patients With Type 2 Diabetes on Basal Insulin. Clin Diabetes. 2015 Oct;33(4):175-80. doi: 10.2337/diaclin.33.4.175.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- JSS/MC/PG/25MC/2024-25
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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