Effect of Nutritional Product Plus Metformin as Compared to Comparator Food Product Plus Metformin in Regulating Blood Glucose in Diabetes Mellitus

Not Applicable

Completed

• Registration Number: CTRI/2018/02/012013
• Lead Sponsor: ITC Life Sciences and Technology Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 383

Inclusion Criteria

Subjects who meet all of the following criteria will be included in the study:

ïÆ?¼Males and females >35 and <65 years of age

ïÆ?¼A fasting plasma glucose of >126 mg/dL)

ïÆ?¼HbA1c ââ?°Â¥6.5% and ââ?°Â¤10%

ïÆ?¼Patients willing to comply with diet control and exercise

ïÆ?¼Patients with regular consumption of wheat flour (minimum in 2 meals a day) ââ?¬â?? approx. 3kg wheat flour consumption per person per month

ïÆ?¼Patients with history of stable weight, defined as no significant weight change within three months prior to enrollment

ïÆ?¼If on anti-hypertensive therapy, lipid-lowering agents, or thyroid medications, the dosage must be constant for at least 2 months prior to the screening visit

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study:

ïÆ?¼Body mass index greater than 30

ïÆ?¼Type 1 diabetes mellitus or secondary diabetes mellitus

ïÆ?¼Currently taking any other herbal products, dietary supplements, or medications during the past 8 weeks that could affect plasma glucose

ïÆ?¼Pregnant or lactating women

ïÆ?¼Patients requiring a fibre free diet

ïÆ?¼Patients requiring enteral tube feed or parenteral nutrition

ïÆ?¼Diagnosed with an eating disorder such as bulimia or binge eating

ïÆ?¼Any acute gastrointestinal disease within 2 weeks prior to study entry

ïÆ?¼Cancer cachexia

ïÆ?¼Clinically significant cardiac disease or endocrine abnormalities other than stable thyroid disease

ïÆ?¼Suspicion of drug abuse, abuse of/addiction to alcohol

ïÆ?¼Untreated major psychiatric disorder

ïÆ?¼History of bariatric surgery

ïÆ?¼Known HIV positive

ïÆ?¼Serum creatine of ââ?°Â¥1.5 mg/dL

ïÆ?¼Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ââ?°Â¥2.5 X Upper Limit of Normal (ULN

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant difference in level of HbA1c in Nutritional Product consuming pre diabetic and Diabetic Patients at 12th week as compared to 0th day.Timepoint: Significant difference in level of HbA1c in Nutritional Product consuming pre diabetic and Diabetic Patients at 12th week as compared to 0th day.

Secondary Outcome Measures

Name	Time	Method
Changes in HbA1c%Timepoint: 0th,6th week and 12th week