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Development of Anti-Diabetic Nutraceuticals From Legume Seed Coats

30 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Anmälan via inbjudan

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in Fasting blood glucose and HbA1c at 4 weeks
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in Total cholesterol, triglycerides, LDL, HDL at 4 weeks
Tidsram: 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
Tidsram: 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
Tidsram: Baseline and 4th week
Serum cytokines measurement by immunoassay
Baseline and 4th week
Change from baseline in serum creatinine at 4 weeks
Tidsram: 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
Tidsram: 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
Tidsram: Baseline and 4th week
Body weight measurement using adigital scale
Baseline and 4th week

Samarbetspartners och utredare

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Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 juni 2026

Primärt slutförande (Beräknad)

15 juli 2027

Avslutad studie (Beräknad)

22 juli 2027

Studieregistreringsdatum

Först inskickad

30 juni 2026

Först inskickad som uppfyllde QC-kriterierna

30 juni 2026

Första postat (Faktisk)

7 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juni 2026

Senast verifierad

1 juni 2026

Mer information

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