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
Scientific Title of Study
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
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
AETL/CT/003/2024, Version no 1, dated 28/12/2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,
Intervention / Comparator Agent
Type
Name
Details
Intervention
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
Comparator Agent
Placebo
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
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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)].
Method of Generating Random Sequence
Other
Method of Concealment
Not Applicable
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Change in HbA1c (assessment on Day -1 to Day -7, Day 90 and Day 180)
180 days
Secondary Outcome
Outcome
TimePoints
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
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.
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, Bloating, Abdominal cramps and heartburn experienced during the study. The tolerability will be evaluated by the intensity of each individual symptom on a validated 5-point Likert scale
(0-no problem, 1- mild problem, 2- moderate problem, 3- severe problem and 4- very severe problem)
12. Rate of incidence of AE and SAEs Recording any adverse (AE) or serious adverse event (SAE) from Day 1 to Day 180
180 days
Target Sample Size
Total Sample Size="90" Sample Size from India="90" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
T2DM can be a long term condition that requires extended blood sugar management, the combined approaches such as pharmacological, physical and, in recent years, therapeutic interventions directed at the microbiome are the most effective in managing it (Diagnosis and Classification of Diabetes mellitus, 2013). While standard formulations which include insulin, metformin and SGLT2 inhibitors assist patients manage their blood glucose levels, they rarely come without a fair share of side effects such as hypoglycemia, weight gain or gastrointestinal problems (Wilcox et al., 2020). They do not, however, resolve the underlying problems that lead to insulin resistance and beta-cell dysfunction. For this reason, there has been a growing need to look for new and safer, and combined therapies that help not only control hyperglycemia but also treat underlying conditions, the imbalanced metabolic state (Cerf, 2013). The enzyme blend GlucoSEB Plus PB can be a part of diabetic care regimen. The enzymes modulate carbohydrate metabolism while probiotics support in improving gut health. Numerous studies have reported that the gut microflora is closely related to body metabolism. An imbalance of intestinal microbiota, or dysbiosis, is one characteristic of T2DM that leads to metabolic dysregulation by causing insulin resistance, systemic inflammation and increased gut permeability (Hou et al., 2022, Wu et al., 2023,Xia et al., 2021). GlucoSEB Plus PB consists of components that have gut microbiome targeted mechanisms primarily focused on enhancing metabolic parameters in patients with diabetes rather than solely targeting the reduction of dysglycemia.
The aim of evaluating GlucoSEB Plus PB is described as follows, 1. Metabolic Health - The enzymes blend is useful in decreasing the glycemic index of consumed carbohydrates by controlling the free glucose into the bloodstream, thus lowering blood glucose levels after a meal. This might have special significance in avoiding glucose toxicity which is one of the factors that lead to insulin resistance. The manufacture of prebiotic fibers also helps in metabolic health by altering the gut microbiota which may increase insulin sensitivity and decrease systemic inflammation levels. 2.Gut microbiome modulation - Since there is a wealth of data associating gut dysbiosis and T2DM, promoting good gut bacteria through GlucoSEB Plus PB is of particular interest. There are studies that support the use of Probiotics as adjunct therapy for blood sugar control and those that reduce inflammation and improve metabolic disease. Since GlucoSEB Plus PB may promote a healthier microbiome, it may also have a wider effect on metabolic health other tham dysglycemia.
GlucoSEB Plus PB treatment combines the benefits of targeting metabolic and gut health to diminish the ill effects caused due to diabetes. GlucoSEB Plus PB is an advanced therapy that promises new avenues aimed at diabetes management.