NCT05453838

Bioequivalence of a Diabetes Specific Tube Feed

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Nutricia Research · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postprandial Glucose Response

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	oral intake of one serving of the original and new product	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

Timeline

• Start date: 2022-09-07
• Primary completion: 2022-11-29
• Completion: 2022-11-29
• First posted: 2022-07-12
• Last updated: 2025-01-24

Locations

1 site across 1 country: Netherlands