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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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Karnataka
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Mysore, Karnataka, Índia, 570015
- JSS Medical College
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline in Fasting blood glucose and HbA1c at 4 weeks
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline in Total cholesterol, triglycerides, LDL, HDL at 4 weeks
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
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Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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Enviado pela primeira vez que atendeu aos critérios de CQ
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Atualizações de registro de estudo
Última Atualização Postada (Real)
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- JSS/MC/PG/25MC/2024-25
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