Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: Test Biscuit 1: Functional food
Intervention2: Test Biscuit 2: Functional food
Control Intervention1: Placebo Biscuit: Functional food
Sponsors
ITC Life Sciences and Technology Center ITC Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males and females greater than or equal to 30 and lesser than or equal to 65 years of age. 2.Body mass index more than 18.5 kg/m2 and lesser than 30 kg/m2 3.A FBG of greater than or equal to 126 mg/dL (after no caloric intake for at least 10-12 hours) 4.HbA1c greater than or equal to 6.5% and lesser than or equal to 8%. 5.Patients willing to comply with diet control and exercise 6.Patients who have taken only Metformin 500 mg. twice daily, and no other oral hypoglycemic agent, for at least 3 months prior to the screening visit 7.All the patients who will require the same treatment i.e. metformin 500 mg BD for 3months from the start of treatment phase, as per the investigatorâ??s discretion. 8.If any patient is 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. 9.Patients with history of stable weight, defined as no significant weight change (± 5%) within three months prior to enrollment 10.Females of child-bearing potential should be willing to use adequate methods of contraception 11.Must be willing to give written informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes mellitus or secondary diabetes mellitus 2.Currently taking or is required to take any herbal products and dietary supplements, or medications the could affect plasma glucose, other than the metformin during the past 3 months and requiring these for 3 months from the start of treatment phase 3.Pregnant or lactating women 4.Patients requiring a fibre free diet 5.Patients 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 other than stable thyroid disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effects assessed in terms of maintenance and/or mean change in blood glucose (FBG/PPBG) from baseline to Day 84 between test biscuit groups and compare to placebo group.Timepoint: baseline to Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Maintenance and/or mean change in blood sugar (FBG/PPBG). in HbA1c ,in insulin sensitivity and secretion change in body weight, waist circumference and BMI ,in lipid parameters (HDL, LDL, VLDL and TG) . change in C-reactive protein and adiponectin appearance, smell, taste and mouth feel Timepoint: from baseline to Day 21, Day 42, Day 63 and day 84. | — |
Countries
India
Contacts
Public ContactNikhil Patel
Karmic Lifesciences LLP
Outcome results
None listed