Bioequivalence of a Diabetes Specific Tube Feed

NCT05453838 | Completed

• 1 other identifier: SBB22R&40700
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Glucose Response

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• GI new product

  120 minutes

• GL new product

  120 minutes

Study Arms (2)

New product - Original product

OTHER

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

Original product - New product

OTHER

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

Interventions

oral intake of one serving of the original and new product DIETARY_SUPPLEMENT

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

New product - Original product; Original product - New product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

NCRU

Utrecht, 3582CT, Netherlands

Location

Study Officials

• Monique Visser, PhD

  Nutricia Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: September 7, 2022
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)