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Development of Anti-Diabetic Nutraceuticals From Legume Seed Coats

30 juin 2026 mis à jour par: Rajesh Kumar T, JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH

Evaluation of Boiled Water Extracts of Legumes Seed Coats for Alpha Amylase and Alpha Glucosidase Activity: Formulation of Anti- Diabetic Nutraceuticals

This open-label clinical trial aims to evaluate whether daily consumption of soup prepared from boiled water extracts of selected legume seed coats, seasoned with salt and spices, improves glycemic regulation in individuals with metabolic syndrome or type 2 diabetes mellitus (T2DM). The primary question is whether daily intake of this palatable legume-based soup enhances glycemic control. Secondary questions include whether it reduces dyslipidemia, oxidative stress, and inflammation in participants with metabolic syndrome or T2DM. Participants will consume the soup once daily for 30 consecutive days. Clinical assessments, including HbA1c, fasting blood glucose, lipid profile, and biomarkers of oxidative stress and inflammation will be conducted at baseline and after the 30-day intervention.

Aperçu de l'étude

Statut

Inscription sur invitation

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Karnataka
      • Mysore, Karnataka, Inde, 570015
        • JSS Medical College

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline in Fasting blood glucose and HbA1c at 4 weeks
Délai: Baseline and 4th week
Fasting blood glucose and plasma HbA1c measured at clinical biochemistry diagnostic laboratory.
Baseline and 4th week
Change from baseline in capillary blood glucose levels after meal at 2 and 4 week
Délai: Baseline, 2nd week and 4th week
Capillary blood glucose levels at baseline, 30 min, 60 min, 90 min and 120 min after a meal by glucometer
Baseline, 2nd week and 4th week

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from baseline in Total cholesterol, triglycerides, LDL, HDL at 4 weeks
Délai: Baseline and 4th week
Lipid profile (total cholesterol, triglycerides, LDL-C, and HDL-C) assessment before and after the intervention at the Clinical Biochemistry Diagnostic Laboratory.
Baseline and 4th week
Change from baseline in circulatory markers of oxidative stress at 4 week
Délai: Baseline and 4th week
Serum total antioxidant capacity (TAC) and serum free thiols measurement using spectrofluorometry and spectrophotometry.
Baseline and 4th week
Change from baseline in circulatory markers of inflammation at 4 weeks
Délai: Baseline and 4th week
Serum cytokines measurement by immunoassay
Baseline and 4th week
Change from baseline in serum creatinine at 4 weeks
Délai: Baseline and 4th week
Serum creatinine levels measurement at clinical biochemistry diagnostic laboratory
Baseline and 4th week
Change from baseline in Systolic blood pressure & Diastolic Blood pressure at 4 weeks
Délai: Baseline and 4th week
Blood pressure measurement using a digital blood pressure monitor
Baseline and 4th week
Change from baseline in bodyweight at 4 weeks
Délai: Baseline and 4th week
Body weight measurement using adigital scale
Baseline and 4th week

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Rajesh K Thimmulappa, JSS Academy of Higher Education and Research

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 juin 2026

Achèvement primaire (Estimé)

15 juillet 2027

Achèvement de l'étude (Estimé)

22 juillet 2027

Dates d'inscription aux études

Première soumission

30 juin 2026

Première soumission répondant aux critères de contrôle qualité

30 juin 2026

Première publication (Réel)

7 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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