A clinical trial to evaluate the safety of GlucoSEB plus PB and its impact on metabolism and gut health when exposed to adult participants with diabetes

A randomized, double blind, parallel, placebo-controlled study to evaluate metabolic health and gut microbiome in presence of GlucoSEB Plus PB in diabetic adults as integrative care - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079803

Enrollment

Registered

2025-01-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: GlucoSEB plus PB: 500 mg, two capsules per meal (lunch and dinner), oral route of administration, swallow as a whole with water just before having meal, for 180 days Control Interventio

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects with less physical activity 2. BMI 18.5 to 35 Kg per m2 3. Subjects with recent HbA1c reports within 2 weeks can be considered as screening value for participation in the study. 4. Subjects taking stable medicine dose for past 3 months 5. Subjects who occasionally consume sweets 6. Subjects with fasting blood sugar level greater than or equal to 130 mg/dL and HbA1c 7.0 to 11.0% 7. Subjects must have a history of diabetes for more than 1 year and have been on a stable medication regimen for at least the past 9 months 8. Subjects willing to give written informed consent and adhere to all the requirements of this protocol

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating female. 2. Subjects with BMI greater than or equal to 35 3. Type I diabetic patients 4. HbA1c less than 7.0 and greater than 11.0% 5. Diabetes medication (DPP4 inhibitors, Acarbose, Voglibose, Repaglinide, GLP 1 receptor agonists (GLP1RA), and Insulin) 6. Patients with major chronic complications (including but not limited to) autoimmune disease, inflammation, etc. 7. Organic insufficiency (cardiac, hepatic, renal, respiratory) 8. Use of food supplements specifically containing fibers or polysaccharides 9. Chronic smoking and alcohol intake 10. Allergy to the ingredients in the test product. 11. History of any surgery in the past 3 months. 12. Subject currently taking or has in the past 30 days used GI related probiotics/prebiotics or any enzymes [prescription or over the counter (OTC)].

Design outcomes

Primary

Measure	Time frame
Change in HbA1c (assessment on Day -1 to Day -7, Day 90 and Day 180)Timepoint: 180 days	—

Secondary

Measure	Time frame
1. Change in fasting blood glucose (assessment on Day -1 to Day -7, Day 90 and Day 180). 2. Change in fasting insulin (assessment on Day 1, Day 90 and Day 180) 3. Calculate- HOMA-IR score- fasting insulin (microIU per ml) X fasting glucose (mmol per L) divided by 22.5 a. Beta-cell function (HOMA-Beta): [20 X Fasting insulin (MicroIU per mL)] divided by [Fasting glucose (mmol per L) 3.5] b. Disposition index (DI): DI = 450 divided by [(FPG)2 (FPG X 3.5)] Quantitative insulin sensitivity check index (QUICKI)- QUICKI is equal to 1 divided by [log(fasting insulin microIU per mL) plus log(fasting plasma glucose mg per dL)] 3. Change in Lipid profile (assessment on Day 1, Day 90 and Day 180) Quantification of TC, TG, LDL, HDL, VLDL Timepoint: 180 days;4. Change in anthropometric parameters (assessment on Day -1 to Day -7, Day 1, Day 90 and Day 180) Body mass index (BMI), Waist circumference (WC), Waist-to-hip ratio (WHR), Body fat percentage (BFP) 5. Assess the peak plasma levels of Glucagon Like peptide-1 (GLP-1) at day 1 and day 180. 6. Change in Gut microbiome (assessment on Day 1 and Day 180) Microbiota analysis of subjects from test and placebo arm (randomly selected 5 subjects from each arm on Day 1) 7. Questionnaire based assessment Hunger and satiety scale, 36-Item Short Form Survey Instrument (SF- 36) on Day 1, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90, Day 105, Day 120, Day 135, Day 150, Day 165, and Day 180. Timepoint: 180 days;8. Liver and Renal safety (assessment on Day 1, Day 90 and Day 180) Check levels of AST, ALT, hsCRP, BUN, total albumin and globulin. 9. CBC analysis on day 1, Day 90 and Day 180 and vital sign measurement (assessment on Day -1 to Day -7, Day 1, Day 90 and Day 180) 10. Monitoring subjects for any side effects occurred during the treatment. (weekly follow up- telephonic or paper record) 11. Tolerability- The tolerance of the product by participants assessments for any side effect such as Nausea, Vomiting, Bloati	—

Measure

Time frame

1. Change in fasting blood glucose (assessment on Day -1 to Day -7, Day 90 and Day 180). 2. Change in fasting insulin (assessment on Day 1, Day 90 and Day 180) 3. Calculate- HOMA-IR score- fasting insulin (microIU per ml) X fasting glucose (mmol per L) divided by 22.5 a. Beta-cell function (HOMA-Beta): [20 X Fasting insulin (MicroIU per mL)] divided by [Fasting glucose (mmol per L) 3.5] b. Disposition index (DI): DI = 450 divided by [(FPG)2 (FPG X 3.5)] Quantitative insulin sensitivity check index (QUICKI)- QUICKI is equal to 1 divided by [log(fasting insulin microIU per mL) plus log(fasting plasma glucose mg per dL)] 3. Change in Lipid profile (assessment on Day 1, Day 90 and Day 180) Quantification of TC, TG, LDL, HDL, VLDL Timepoint: 180 days;4. Change in anthropometric parameters (assessment on Day -1 to Day -7, Day 1, Day 90 and Day 180) Body mass index (BMI), Waist circumference (WC), Waist-to-hip ratio (WHR), Body fat percentage (BFP) 5. Assess the peak plasma levels of Glucagon Like peptide-1 (GLP-1) at day 1 and day 180. 6. Change in Gut microbiome (assessment on Day 1 and Day 180) Microbiota analysis of subjects from test and placebo arm (randomly selected 5 subjects from each arm on Day 1) 7. Questionnaire based assessment Hunger and satiety scale, 36-Item Short Form Survey Instrument (SF- 36) on Day 1, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90, Day 105, Day 120, Day 135, Day 150, Day 165, and Day 180. Timepoint: 180 days;8. Liver and Renal safety (assessment on Day 1, Day 90 and Day 180) Check levels of AST, ALT, hsCRP, BUN, total albumin and globulin. 9. CBC analysis on day 1, Day 90 and Day 180 and vital sign measurement (assessment on Day -1 to Day -7, Day 1, Day 90 and Day 180) 10. Monitoring subjects for any side effects occurred during the treatment. (weekly follow up- telephonic or paper record) 11. Tolerability- The tolerance of the product by participants assessments for any side effect such as Nausea, Vomiting, Bloati

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Countries

India

Contacts

Public ContactDr Mukul Maurya

Advanced Enzymes Technologies Limited

akrathi@advancedenzymes.com9970092220

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026