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OpenTrials
Completed

NCT Number: NCT05453838

Bioequivalence of a Diabetes Specific Tube Feed

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.

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Key information

Conditions

Postprandial Glucose Response

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NCRU

Utrecht, 3582CT, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Employees of Nutricia Research and/or family members or relatives of employees

Treatment and study plan

oral intake of one serving of the original and new product

Dietary Supplement
  • 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

Primary outcomes

  1. Blood glucose - Product A versus Product B

    Time frame: 120 minutes

    Blood glucose iAUC0-120 [mmol/L*min] [mmol/L]

  2. Blood glucose - Product A versus Product B

    Time frame: 120 minutes

    Blood glucose iCmax [mmol/L] [mmol/L]

Secondary outcomes

  1. GI new product

    Time frame: 120 minutes

    GI = blood glucose iAUC0-120 [mmol/L] of new product / mean blood glucose iAUC0-120 [mmol/L] of reference product

  2. GL new product

    Time frame: 120 minutes

    GL = GI * available carbohydrate/given amount of carbohydrate

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Acronym: EQUIDIA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2022
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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