Bioequivalence of a Diabetes Specific Tube Feed (EQUIDIA)

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.

Study Overview

• Status: Completed
• Conditions: Postprandial Glucose Response
• Intervention / Treatment: Dietary supplement: oral intake of one serving of the original and new product

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3582CT
    • NCRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age ≥ 18 and ≤ 65 years
2. Body Mass Index (BMI) ≥ 18.5 and ≤ 27.0 kg/m2
3. Written informed consent
4. Willingness and ability to comply with the protocol
5. Judged by the Investigator to be in good health

Exclusion Criteria:

1. Known Diabetes Mellitus type I or type II, rebound hypoglycaemia and/or any other medical condition that interferes with glucose metabolism
2. 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
3. Any known disease which influences digestion and absorption of nutrients within 1 week of screening (in the opinion of the Investigator)
4. Allergy to soy and/or any other known relevant food allergy or intolerance in opinion of the Investigator
5. Adherence to a strict vegan diet
6. Adherence to a weight loss program
7. Picky/fussy eater (being very selective about what to eat) or eating disorder
8. Known pregnancy and/or lactation
9. 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)
10. Average alcohol use of > 21 glasses per week for men or > 14 glasses per week for women (on average during the last 6 months)
11. Drug or medicine abuse in opinion of the Investigator
12. Any known bleeding disorder
13. 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
14. 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
15. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
16. Employees of Nutricia Research and/or family members or relatives of employees

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: New product - Original product; 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; 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
Other: Original product - New product; 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; 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

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

Collaborators and Investigators

• Sponsor: Nutricia Research
• Investigators: Principal Investigator: Monique Visser, PhD, Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Actual): November 29, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SBB22R&40700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No