Evaluating Gastrointestinal Effects Of Fenugreek In Patients Suffering From T2DM

Title:

Evaluation of Trigonella foenum-graecum (Fenugreek) on Gastrointestinal Symptoms and Glycemic Control in Patients with Type 2 Diabetes Mellitus

Background:

Type 2 Diabetes Mellitus (T2DM) is frequently associated with gastrointestinal (GI) complications such as gastroparesis, constipation, bloating, and dyspepsia. Anti-diabetic medications like Metformin, Glimepiride, and Voglibose also cause GI side effects. These factors adversely affect quality of life and glycemic management.

Fenugreek (Trigonella foenum-graecum), widely used in Indian diets and described in Ayurveda as Prameha nashaka (anti-diabetic), has shown hypoglycemic, appetite-regulating, and GI-modulating properties. Preliminary studies suggest improvement in appetite, bowel movements, and a favorable trend in glucose control with Fenugreek.

Rationale:

There is limited research on the effect of Fenugreek on GI symptoms and gut hormones in T2DM. This study aims to explore its role as a safe, culturally acceptable adjunct in diabetes management.

Objectives:

To evaluate the effect of Fenugreek on GI symptoms in patients with T2DM

To assess its impact on glycemic profile (fasting glucose, postprandial glucose, HbA1c, insulin)

To evaluate safety through clinical monitoring and laboratory tests

Study Design:

Type: Single-arm, exploratory clinical study

Sample size: 36 patients (30 completed, considering 20 percent dropout)

Setting: Recruitment from College of Ayurveda; procedures at IRSHA, Bharati Vidyapeeth University, Pune

Intervention: Fenugreek seed powder standardized, roasted, and compressed into 500 mg tablets. Patients will take 3 g/day (3 tablets twice daily before meals) for 3 months

Follow-up: Monthly clinical visits (Day 30, 60, 90) and telephonic check-ins

Eligibility:

Inclusion:T2DM patients (30-55 years), HbA1c less than or equal to 9 percent, GI complaints (bloating, fullness, nausea, constipation for one month or more)

Exclusion: Insulin therapy, acute gastric or intestinal disorders, concurrent herbal or nutritional supplements, severe organ dysfunction, psychiatric disorders, pregnancy or lactation, participation in another trial

Assessments:

Clinical and Questionnaires: Agni (Ayurvedic digestion scale), Diabetes Bowel Syndrome Questionnaire (DBSQ), Simplified Nutritional Appetite Questionnaire (SNAQ)

Biochemical: Fasting and postprandial glucose, HbA1c, fasting insulin, Liver Function Test, Renal Function Test, Complete Blood Count

Anthropometry and Body Composition: Weight, BMI, waist circumference

Safety: Adverse events, rescue medication if required

Data Analysis:

Parametric data: Mean plus/minus SD, Paired t-test

Non-parametric data: Median (Range), Wilcoxon signed-rank test

Categorical data: Chi-square test

Statistical significance at p less than 0.05

Expected Outcome:

Fenugreek supplementation may reduce GI symptoms, improve appetite and bowel habits, and support better glycemic control, while being safe and well-tolerated. Stored serum samples may provide further insights into GI hormone mechanisms.

Societal and National Relevance:

The study addresses India’s rising diabetes burden by investigating a culturally accepted, diet-based Ayurvedic intervention. It supports national missions on integrating traditional medicine into modern healthcare, with the potential to improve quality of life and reduce medication-related GI side effects.