Health Condition 1: null- Pre-diabetes
Conditions
Interventions
Intervention1: Test Biscuit 2: 3 Biscuits Twice daily
Route of administration: oral
Duration: 84 days
Intervention2: Placebo: 3 Biscuits Twice daily
Route of administration: oral
Duration: 84 days
Con
Sponsors
ITC Life Sciences and Technology Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females greater than or equal to 18 and less than or equal to 65 years of age 2. Body mass index of greater than or equal to 18.5 and less than or equal to 30 kg per m2 3. Pre-diabetic subjects with fasting blood glucose between 100 and 125 mg/dL (called impaired fasting glucose or IFG), IGT (greater than or equal to 140 and less than 200), and HbA1c levels greater than or equal to 5.7% and less than or equal to 6.4% 4. Subjects willing to comply with diet control 5. Subjects with history of stable weight, defined as no significant weight change (less than ±5%) within three months prior to enrollment 6. If on anti-hypertensive therapy, the dosage must be constant for at least 2 months prior to the screening visit, based on medical history. 7. Females of child-bearing potential and males should be willing to use adequate methods of contraception. 8. Must be willing to give written informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Type 1 or type 2 diabetes mellitus 2. Subject with lipid abnormalities or thyroid disorders 3. Pregnant or lactating women 4. Subjects requiring a fibre free diet 5. Subject requiring enteral tube feed or parenteral nutrition 6. Diagnosed with an eating disorder such as bulimia or binge eating 7. Any acute gastrointestinal disease within 2 weeks prior to study entry 8. History of Cancer 9. Clinically significant cardiac disease or endocrine abnormalities 10. Suspicion of drug abuse, abuse of/addiction to alcohol 11. Untreated major psychiatric disorder 12. History of bariatric surgery 13. Known HIV positive 14. Serum creatinine of greater than or equal to 1.5 mg per dL 15. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values greater than or equal to 2.5 X Upper Limit of Normal (ULN)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects assessed in terms of maintenance and/or mean change in blood glucose (FBG, PPBG) from baseline to end of treatment i.e. 12 weeks, between the two test biscuit groups and compare to placebo groupTimepoint: At week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Maintenance and /or mean change in HbA1c, QUICKI, body weight, waist circumference, BMI, lipid parameters (HDL, LDL, VLDL and TG), BP,fructosamine levels, adiponectin, PAI-1, IL-6, CRP and safety of biscuitsTimepoint: at week 12 | — |
Countries
India
Contacts
Public ContactNikhil Patel
Karmic Lifesciences LLP
Outcome results
None listed