Impact of GLUBLOC On postprandial blood gulcose and insulin levels in patients with diabetes and healthy individuals post high carb meal intake
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1. To document the impact of
Study Overview
Brief Summary
In the current study we aimed at understanding the anti-diabetic activity of the nutraceutical powder containing glublocâ„¢ (a proprietary blend of Morus alba L and Malus domestica peel extract) in improving the HbA1C, glucose and inulin levels in diabetic individuals. This will be added as a nutraceutical/ dieraty supplement to their current medication and evaluate the improvements in HbA1C, glucose and inulin levels at the end of 3rd month and 6th month of intervention and the assessments were compared to placebo intake
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy subjects: 1.Aged between 18–60 years, 2.BMI between 18.5 and 22.9 kg/m2 3.Fasting blood glucose range between 3.9 and 5.5 mmol/L.
- •Diabetes Patients 1.Aged between 18–60 years, 2.BMI between 18.5 and 29.9 kg/m2 3.Fasting blood glucose ≥ 7.2 mmol/L (or) ≥ 126 mg/dl or HbA1C ≥ 6.5%.
Exclusion Criteria
- •Healthy subjects: 1.Women who were pregnant or lactating 2.Any known food allergies 3.Subjects with a bleeding disorder 4.Pre-existing medical condition or taking medication known to affect glucose regulation and/or influence digestion and absorption of nutrients 5.History of diabetes mellitus (type I/II) or they used antihyperglycaemic drugs or insulin to treat diabetes or related conditions 6.Used steroids, protease inhibitors or antipsychotic medicines as these drugs are known to impact glucose metabolism and body fat distribution.
- •Diabetes Patients: 1.food allergies.
- •2.Used steroids, protease inhibitors or antipsychotic medicines as these drugs are known to impact glucose metabolism and body fat distribution.
- •3.Subjects with the history of uncontrolled hypertension and/or hyperthyroidism.
- •4.History of alcoholism 5.Subjects with psychiatric or neurological disability or mental health disorder 6.Subjects with serious health conditions such as cardiac disease, renal dysfunction, and cancers.
- •7.Female subjects who are pregnant or had planned for pregnancy in the following months or were breast-feeding.
- •8.Subjects who refuse to sign informed consent.
- •9.According to the investigator’s opinion, participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable.
Outcomes
Primary Outcomes
1. To document the impact of
Time Frame: Baseline samples before intervention, end of the 3rd Month and end of the six month
GLUBLOC supplementation in patients with diabetes and healthy
Time Frame: Baseline samples before intervention, end of the 3rd Month and end of the six month
individuals
Time Frame: Baseline samples before intervention, end of the 3rd Month and end of the six month
Secondary Outcomes
- To document adverse effect if any on study product(Baseline samples before intervention, end of the 3rd Month and end of the six month)
Investigators
Balamurugan Ramadass
All India Institute of Medical Sciences