Bioequivalence of a Diabetes Specific Tube Feed

Study Overview
=================
Brief Summary
-----------------
Nutricia has a range of nutritionally complete tube feeds on the market including some specific for diabetes patients. A new product is currently under development. The aim of the present study is to assess whether the postprandial glucose response of the new product is equivalent to the postprandial glucose response of an original product. In addition, the Glycaemic Index (GI) and Glycaemic Load (GL) of the adapted product will be determined. The study will have a crossover design with healthy volunteers taking one serving of both products in a randomized order. To determine GI and GL of the adapted product subjects will also receive a reference product. Subjects will visit the study site six times: one screening visit, three study visits to measure the glucose response to the reference product and two study visits to measure the glucose response to the test and control product.

Official Title
-----------------
Bioequivalence of a Diabetes Specific Tube Feed

Conditions
-----------------
Postprandial Glucose Response

Intervention / Treatment
-----------------
* Dietary Supplement: oral intake of one serving of the original and new product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 and ≤ 65 years Body Mass Index (BMI) ≥ 18.5 and ≤ 27.0 kg/m2 Written informed consent Willingness and ability to comply with the protocol Judged by the Investigator to be in good health Exclusion Criteria: Known Diabetes Mellitus type I or type II, rebound hypoglycaemia and/or any other medical condition that interferes with glucose metabolism Any use of anticoagulants, systemic steroids, protease inhibitors or antipsychotics and/or any medication known to affect glucose tolerance and/or to influence digestion and absorption of nutrients within 1 week of screening, in opinion of the Investigator Any known disease which influences digestion and absorption of nutrients within 1 week of screening (in the opinion of the Investigator) Allergy to soy and/or any other known relevant food allergy or intolerance in opinion of the Investigator Adherence to a strict vegan diet Adherence to a weight loss program Picky/fussy eater (being very selective about what to eat) or eating disorder Known pregnancy and/or lactation Current smoking or stopped smoking for < 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/cigars/pipes per week on average in the last month) Average alcohol use of > 21 glasses per week for men or > 14 glasses per week for women (on average during the last 6 months) Drug or medicine abuse in opinion of the Investigator Any known bleeding disorder Active participation in any other clinical study with investigational or marketed products concomitantly or within 4 weeks before study visit 1, in the opinion of the Investigator Major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the Investigator Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements Employees of Nutricia Research and/or family members or relatives of employees

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: New product - Original product<br>All subjects will receive first product A and then product B. In addition, the reference product will also be received (three times a glucose solution during the trial). | Dietary Supplement: oral intake of one serving of the original and new product<br>* 1) Intervention type: Dietary Supplement Intervention name: (visits 1, 3 and 5) Reference product Intervention description: Glucose solution 2) Intervention type: Dietary Supplement Intervention name: (visit 2 or 4) Diabetes specific tube feed Intervention description: : One serving new product 3) Intervention type: : Dietary Supplement Intervention name: (visit 2 or 4) Diabetes specific tube feed Intervention description: One serving original product<br>|
| Other: Original product - New product<br>All subjects will receive first product B and then product A. In addition, the reference product will also be received (three times a glucose solution during the trial). | Dietary Supplement: oral intake of one serving of the original and new product<br>* 1) Intervention type: Dietary Supplement Intervention name: (visits 1, 3 and 5) Reference product Intervention description: Glucose solution 2) Intervention type: Dietary Supplement Intervention name: (visit 2 or 4) Diabetes specific tube feed Intervention description: : One serving new product 3) Intervention type: : Dietary Supplement Intervention name: (visit 2 or 4) Diabetes specific tube feed Intervention description: One serving original product<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose - Product A versus Product B | Blood glucose iAUC0-120 [mmol/L*min] [mmol/L] | 120 minutes | 
| Blood glucose - Product A versus Product B | Blood glucose iCmax [mmol/L] [mmol/L] | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI new product | GI = blood glucose iAUC0-120 [mmol/L] of new product / mean blood glucose iAUC0-120 [mmol/L] of reference product | 120 minutes | 
| GL new product | GL = GI * available carbohydrate/given amount of carbohydrate | 120 minutes |