Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: 1 Sachet of The Good Bug Glycemic Control (1.8 g) + 1 scoop (8g) The Good Bug Metabolic Fiber Boost: Both in 200 ml water, 15 minutes before
breakfast for 90 days with nutritional couns
Sponsors
Seven Turns Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and females aged 30-45 years (both inclusive);2.Participants with glycated hemoglobin (HbA1c) levels 8 % to 11% (both inclusive);3.Participants diagnosed and treated for more than 6 months for type 2 diabetes;4.Participants on oral hypoglycemic (OHA) medication treatment alone or in combination with oral antidiabetic drugs (metformin and/or sulfonylureas only) in a stable dose for at least 3 months prior to randomization;5.Participants providing voluntary, written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Presence of Type I diabetes Mellitus (T1DM); 2. Participants receiving insulin/other injectables, antidiabetic drugs including 1 (GLP-1) analogues, dipeptidyl peptidase 4 (DPP4) inhibitors, etc.) except for those specified in the inclusion criteria; 3. Severe diabetes-related complications at screening (i.e., end-stage diabeticn kidney disease, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy, any neuro-motor conditions/neurogenic conditions); 4. Regular intake of any herbal phytoinsulin product, probiotics, prebiotics, or antibiotics for 3 months prior to inclusion; 5. Previously diagnosed allergy to probiotics; 6. Gastrointestinal disorders including food allergy, gluten-sensitive enteropathy, ulcerative colitis; 7. An uncontrolled cardiovascular or respiratory disease, an active malignant tumor, chronic infections, chronic bowel disorders, including but not limited to IBS; 8. Participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated); 9. Participants had undergone any surgical procedures within the previous six months; 10. Participation in another clinical trial; 11. Pregnancy or lactation as well as women with childbearing potential not taking adequate contraceptive precautions; 12. Participants with known renal and liver impairment; 13. Participants with a myocardial infarction or stroke within 6 months before study enrolment; 14. Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking; 15. Participants with neurological conditions; 16. Participants with diagnosed PCOD/ PCOS; 17. Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in Glycated Hemoglobin (HbA1c) levels. 2. Changes in Fasting Plasma Glucose (FPG), postprandial plasma glucose (PPG), fasting insulin levels, Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), and Homeostasis Model Assessment of Beta-Cell Function calculated (HOMA-B calculated). 3. Changes in Lipid Profile parameters (Total Cholesterol, LDL-C, HDL-C, non-HDL-C, Triglycerides).Timepoint: 1. At screening and day 90 (end of the study). 2. At screening, day 30, day 60, and day 90. 3. At screening and day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of Body Mass Index (BMI) 2. Assessing Gut health using a Gastrointestinal Symptom Rating Scale (GSRS) score. 3. Changes in the participant-reported bowel habits 4. Assessment of HRQOL-15D score (Health Related Quality of Life) will be measured. 5. Assessment of medication adherence using the 8-item Morisky Medication Adherence Scale (MMAS-8) administered. 6. Evaluation of sensory characteristics through organoleptic studies/sensory analysis. 7. Changes in glucagon-like peptide (GLP-1) levels.Timepoint: 1. At screening, day 30, day 60, and day 90. 2. At screening, day 30, day 60, and day 90. 3. At screening, day 30, day 60, and day 90. 4. At screening and day 90. 5. At day 30, day 60, and day 90. 6. At day 30, day 60 and day 90. 7. At baseline and day 90. | — |
Countries
India
Contacts
Public ContactKaynat Mirajkar
Seven Turns Pvt. Ltd.
Outcome results
None listed