Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes

Study Overview
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Brief Summary
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Effects of a plant based ingredient on blood glucose in Type II diabetes patients.

Detailed Description
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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.

Official Title
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Effect of Plant-based Ingredient on Post Prandial Glucose in Untreated Type II Diabetes Patients

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Low dose plant based ingredient
* Dietary Supplement: High dose plant based ingredient
* Dietary Supplement: Reference food format


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose plant based ingredient<br>Reference food with low dose of plant based ingredient | Dietary Supplement: Low dose plant based ingredient<br>* Reference food with low dose of plant based ingredient<br>|
| Active Comparator: High dose plant based ingredient<br>Reference food with high dose of plant based ingredient | Dietary Supplement: High dose plant based ingredient<br>* Reference food with high dose of plant based ingredient<br>|
| Placebo Comparator: Reference food format<br>Reference food without plant-based ingredient | Dietary Supplement: Reference food format<br>* Reference food without plant-based ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post prandial blood glucose positive incremental area under the curve |  | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post prandial insulin area under the curve |  | 120 minutes |