ClinicalTrials.gov record NCT07688694

Development of Anti-Diabetic Nutraceuticals From Legume Seed Coats

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.

Age20 years old to 60 years old

SexAll

LocationIndia

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This open-label, single-group trial tests whether daily consumption of a legume seed‑coat soup affects blood sugar control and related metabolic markers. Participants (including people with metabolic syndrome, type 2 diabetes, and healthy volunteers) will consume the soup daily for four weeks. Blood tests and finger‑prick glucose checks are taken at the start and after the 4‑week period.

What it is studying. The study is testing whether daily intake of a prepared soup made from boiled extracts of legume seed coats (Vigna mungo or Macrotyloma uniflorum), taken as a 200 ml portion each day for four weeks, changes measures of glycemic control (fasting glucose, HbA1c, and post‑meal capillary glucose), and whether it alters lipid levels, markers of oxidative stress, markers of inflammation, kidney function (serum creatinine), blood pressure, and body weight.

What the researchers hope to learn. To determine whether a legume seed‑coat soup produces measurable changes in blood sugar control (fasting glucose, HbA1c, postprandial glucose) and in lipid profile, oxidative stress markers, and inflammation; to translate prior laboratory findings on legume seed‑coat extracts into a dietary nutraceutical approach for prevention or management of hyperglycemia and related metabolic disturbances.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Dietary supplement: Legumes seed soup

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will consume 200 ml of the legume seed coat soup once daily for four weeks (Sundays excluded), with delivery scheduled between 10:00 and 12:00. Clinical measurements and blood draws are done at baseline and after the four-week intervention to measure fasting glucose, HbA1c, lipid profile, creatinine, and markers of oxidative stress and inflammation, plus weight and blood pressure. Capillary (fingerstick) blood glucose will be checked by glucometer at baseline, at 2 weeks, and at 4 weeks with post-meal readings (30, 60, 90, 120 minutes) as specified.

How the study is structured. Open‑label, single‑group (all participants receive the same intervention) pre‑post intervention. Participants consume the legume seed‑coat soup daily for four weeks; clinical measurements and blood samples are taken at baseline and after four weeks, with finger‑prick glucose checks at baseline, two weeks, and four weeks. There is no placebo, masking, or randomization.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Postprandial Hyperglycemia; Type 2 Diabetes; Metabolic Syndromes. Does it apply to my diagnosis?
The registry says participants are enrolled by invitation. Who decides who is invited, and how?
The listed sites are in India. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start: Jun 22, 2026
Primary completion: Jul 15, 2027 (estimated)
Study completion: Jul 22, 2027 (estimated)
Target enrollment: 100 participants (estimated)
Last updated on registry: Jul 7, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH
Principal investigator: Rajesh Kumar T, Professor
JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH

Participating sites (1)

JSS Medical College
Mysore, Karnataka, 570015 · India

Terms used on this page · explanations by MedicalUpdates.ai

open-label: No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
biomarkers: Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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