Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLow dose plant based ingredient
Reference food with low dose of plant based ingredient
DIETARY_SUPPLEMENTHigh dose plant based ingredient
Reference food with high dose of plant based ingredient
DIETARY_SUPPLEMENTReference food format
Reference food without plant-based ingredient
Sponsors
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post prandial blood glucose positive incremental area under the curve | 120 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Post prandial insulin area under the curve | 120 minutes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post prandial blood glucose positive incremental area under the curve | 180 and 240 minutes | — |
| Post prandial insulin area under the curve | 180 and 240 minutes | — |
| Glucose levels in urine | 240 minutes | — |
| Intestinal discomfort | 240 minutes | Intestinal discomfort will be evaluated by a paper and pen questionnaire in the subject's native language directed to intestinal symptoms (nausea, flatulence, bloating and abdominal pain). |
Countries
India
Outcome results
None listed