Clinical trial NCT05453838: Bioequivalence of a Diabetes Specific Tube Feed
Official title: Bioequivalence of a Diabetes Specific Tube Feed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Glucose Response
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2022-07-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood glucose - Product A versus Product B
timeFrame: 120 minutes
measure: Blood glucose - Product A versus Product B
timeFrame: 120 minutes
Secondary outcomes:
measure: GI new product
timeFrame: 120 minutes
measure: GL new product
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: NCRU
Study officials:
affiliation: Nutricia Research
name: Monique Visser, PhD
role: PRINCIPAL_INVESTIGATOR
References: