A clinical study of a functional food product in Regulating Blood Glucose in Pre-diabetic Subjects
- Conditions
- Health Condition 1: null- Pre-diabetes
- Registration Number
- CTRI/2018/02/012035
- Lead Sponsor
- ITC Life Sciences and Technology Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
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.
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Maintenance and /or mean change in <br/ ><br>HbA1c, QUICKI, body weight, waist circumference, BMI, lipid parameters (HDL, LDL, VLDL and TG), <br/ ><br>BP,fructosamine levels, adiponectin, PAI-1, IL-6, CRP and safety of biscuitsTimepoint: at week 12