A clinical trial to study the effect of resistant starch supplementation on glycemia and gutmicroflora in Indian diabetics

Phase 1

Completed

• Conditions: Health Condition 1: null- Type 2 Diabetes Mellitus

• Registration Number: CTRI/2012/01/002359
• Lead Sponsor: niversity Grant Commission UGC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Patients satisfying all following criteria are included in the study:

1. Patients of either sex between age group 40 ? 60 yrs with a diagnosis of Type 2 Diabetes Mellitus and who are on oral diabetic drugs

2. Patients with fasting blood glucose in between 126 - 170mg/dl and/or postprandial blood glucose in between 150 ? 260mg/dl

3. Patients with HbA1C between 7 ? 11%

4. Patients with BMI more than equal to 35

5. Patients willingness for RS supplementation

6. Non smokers

7. Non alcoholic

Exclusion Criteria

1.Patients suffering from any of the following conditions were excluded from the study.

a.Type 1 diabetes mellitus

b.Patients with severe hyperglycemia (FBS more than 170; PP2BS more than 260)

c.Patients with total cholesterol more than 260mg% and serum triglycerides more than 300mg%

d.Patients with HbA1C more than 9.5%

e.Severe renal, hepatic or respiratory disorder

f.Patients with haemotological disorder

g.Patients with BMI more than equal to 35

h.Severely Anaemic

2.Show allergic symptoms to study food

3.Patients who are likely to undergo surgery during study period

4.Patients who have participated in any investigational study in last 4 weeks

5.Smokers

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reduction in HbA1c levels by 1% as compared to basal values <br/ ><br>Reduction in blood glucose (Fasting and/or postprandial), Increase in beneficial gut microbiota in terms of Lactic acid bacteria and Bifidobacteria by 1%, Reduction in Enteric pathogen counts in gut microbiota by 1% as compared to control at the end of three months treatment <br/ ><br>Less than 10% difference in the adverse events (Including Laboratory variables) between control and active treatment groups. <br/ ><br>Timepoint: on 0 day and at the end of 3 months <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes will be improvement in lipid levels, blood pressure and atherogenic indices after three months treatment from baseline valuesTimepoint: on 0 day and at the end of 3 months