NCT07688694

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jun 2026Jul 2027

Study Start

First participant enrolled

June 22, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2027

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2027

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

June 30, 2026

Last Update Submit

June 30, 2026

Conditions

Postprandial HyperglycemiaType 2 DiabetesMetabolic Syndromes

Keywords

Nutraceuticalpost prandial glucosediabetes preventionlegumealpha-glucosidase inhibitordiet

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in Fasting blood glucose and HbA1c at 4 weeks

    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

    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

Secondary Outcomes (6)

  • Change from baseline in Total cholesterol, triglycerides, LDL, HDL at 4 weeks

    Baseline and 4th week

  • Change from baseline in circulatory markers of oxidative stress at 4 week

    Baseline and 4th week

  • Change from baseline in circulatory markers of inflammation at 4 weeks

    Baseline and 4th week

  • Change from baseline in serum creatinine at 4 weeks

    Baseline and 4th week

  • Change from baseline in Systolic blood pressure & Diastolic Blood pressure at 4 weeks

    Baseline and 4th week

  • +1 more secondary outcomes

Study Arms (1)

Open-label Pre-post Trial of Legume Seed Coat Soup

EXPERIMENTAL

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.

Dietary Supplement: Legumes seed soup

Interventions

Legumes seed soupDIETARY_SUPPLEMENT

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.

Open-label Pre-post Trial of Legume Seed Coat Soup

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JSS Medical College

Mysore, Karnataka, 570015, India

Location

Related Publications (7)

  • 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.

    PMID: 23768145RESULT

  • 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.

    PMID: 9839093RESULT

  • 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.

    PMID: 12876091RESULT

  • 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.

    PMID: 15616251RESULT

  • 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.

    PMID: 24622715RESULT

  • 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.

    PMID: 30592787RESULT

  • 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.

    PMID: 26487791RESULT

MeSH Terms

Conditions

HyperglycemiaDiabetes Mellitus, Type 2Metabolic Syndrome

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Officials

  • Rajesh K Thimmulappa

    JSS Academy of Higher Education and Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Model Description
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

June 22, 2026

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

July 22, 2027

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)