Status:
COMPLETED
Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes
Lead Sponsor:
Unilever R&D
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
Effects of a plant based ingredient on blood glucose in Type II diabetes patients.
Detailed Description
The study is designed to determine the extend to which a plant based ingredient in a food format affects blood glucose responses in untreated Type II diabetes patients.
Eligibility Criteria
Inclusion
- Male and female volunteers with confirmed Type II diabetes not treated with pharmaceutical-based glucose lowering treatment for past three months (controlled solely through diet and exercise);
- Age ≥ 20 and ≤ 65 year at screening;
- Body Mass Index (BMI) between ≥18 and ≤ 32 kg/m2;
- HbA1c ≥48 mmol/mol and ≤53 mmol/mol (≥ 6.5% and ≤ 7.0%). At discretion of the study physician, subjects with HbA1c \>53 mmol/mol and \<58 mmol/mol (\>7.0% and \< 7.5%) controlled solely through diet and exercise are also allowed to participate.
Exclusion
- Being an employee of Unilever or research site;
- Chronic smokers, tobacco chewers and drinkers;
- No medication, including vitamins and tonics, except for cholesterol, as determined by the physician;
- Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening;
- Allergy to any food or cosmetics;
- If female, not being pregnant or planning pregnancy during the study period;
- If female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02256332
Start Date
January 1 2015
End Date
August 1 2015
Last Update
September 23 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA
Thane, Maharashtra, India
2
Lambda Therapeutics Research Ttd (LTRL)
Ahemdabad, India