Bioequivalence of a Diabetes Specific Tube Feed

Postprandial Glucose Response Clinical Trial

— EQUIDIA  

Official title:

Bioequivalence of a Diabetes Specific Tube Feed

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05453838
• Other study ID #: SBB22R&40700
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: July 2022
• Source: Nutricia Research
• Contact: Danone Nutricia Research Danone Research
• Phone: +31302095000
• Email: register.clinicalresearchnutricia[@]danone.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Postprandial Glucose Response

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose - Product A versus Product B	Blood glucose iAUC0-120 [mmol/L*min] [mmol/L]	120 minutes
Primary	Blood glucose - Product A versus Product B	Blood glucose iCmax [mmol/L] [mmol/L]	120 minutes
Secondary	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
Secondary	GL new product	GL = GI * available carbohydrate/given amount of carbohydrate	120 minutes