An interventional study of Legumes seed soup in Postprandial Hyperglycemia, Type 2 Diabetes and Metabolic Syndromes, sponsored by JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH. Enrolling by invitation at 1 site in India. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH · Not applicable, Interventional, and Prevention
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.
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.
800 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 620 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
i. Healthy volunteers aged 20 to \<60 years. ii. Individuals with one or more of the following risk factors: >25 kg/m², systolic blood pressure (SBP) >130 mmHg, dyslipidemia, or 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 disorders.
v. Current use of alpha-glucosidase inhibitor medications.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Change from baseline in Fasting blood glucose and HbA1c at 4 weeks
Fasting blood glucose and plasma HbA1c measured at clinical biochemistry diagnostic laboratory.
Time frame: 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
Time frame: Baseline, 2nd week and 4th week
Change from baseline in Total cholesterol, triglycerides, LDL, HDL at 4 weeks
Lipid profile (total cholesterol, triglycerides, LDL-C, and HDL-C) assessment before and after the intervention at the Clinical Biochemistry Diagnostic Laboratory.
Time frame: Baseline and 4th week
Change from baseline in circulatory markers of oxidative stress at 4 week
Serum total antioxidant capacity (TAC) and serum free thiols measurement using spectrofluorometry and spectrophotometry.
Time frame: Baseline and 4th week
Change from baseline in circulatory markers of inflammation at 4 weeks
Serum cytokines measurement by immunoassay
Time frame: Baseline and 4th week
Change from baseline in serum creatinine at 4 weeks
Serum creatinine levels measurement at clinical biochemistry diagnostic laboratory
Time frame: Baseline and 4th week
Change from baseline in Systolic blood pressure & Diastolic Blood pressure at 4 weeks
Blood pressure measurement using a digital blood pressure monitor
Time frame: Baseline and 4th week
Change from baseline in bodyweight at 4 weeks
Body weight measurement using adigital scale
Time frame: Baseline and 4th week
Plan to share: No
Started Jun 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.
Of 208 non-industry interventional studies with no phase under Hyperglycemia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's planned 12 months is below that.
Counting every sponsor, half of 225 studies reached it within 14 months; a quarter within 7 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
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JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH