None listed
Conditions
Interventions
None listed
Sponsors
ITC Life Sciences and Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria will be included in the study: ïÆ?¼ Males and females >35 and ïÆ?¼ A fasting plasma glucose of >126 mg/dL) ïÆ?¼ HbA1c ââ?°Â¥6.5% and ââ?°Â¤10% ïÆ?¼ Patients willing to comply with diet control and exercise ïÆ?¼ Patients with regular consumption of wheat flour (minimum in 2 meals a day) ââ?¬â?? approx. 3kg wheat flour consumption per person per month ïÆ?¼ Patients with history of stable weight, defined as no significant weight change within three months prior to enrollment ïÆ?¼ If 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
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: ïÆ?¼ Body mass index greater than 30 ïÆ?¼ Type 1 diabetes mellitus or secondary diabetes mellitus ïÆ?¼ Currently taking any other herbal products, dietary supplements, or medications during the past 8 weeks that could affect plasma glucose ïÆ?¼ Pregnant or lactating women ïÆ?¼ Patients requiring a fibre free diet ïÆ?¼ Patients requiring enteral tube feed or parenteral nutrition ïÆ?¼ Diagnosed with an eating disorder such as bulimia or binge eating ïÆ?¼ Any acute gastrointestinal disease within 2 weeks prior to study entry ïÆ?¼ Cancer cachexia ïÆ?¼ Clinically significant cardiac disease or endocrine abnormalities other than stable thyroid disease ïÆ?¼ Suspicion of drug abuse, abuse of/addiction to alcohol ïÆ?¼ Untreated major psychiatric disorder ïÆ?¼ History of bariatric surgery ïÆ?¼ Known HIV positive ïÆ?¼ Serum creatine of ââ?°Â¥1.5 mg/dL ïÆ?¼ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ââ?°Â¥2.5 X Upper Limit of Normal (ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Changes in HbA1c%Timepoint: 0th,6th week and 12th week | — |
Countries
India
Contacts
Public ContactShashidhar KN
Sri Devaraj Urs Medical College
Outcome results
None listed