Postprandial Glucose ResponseEQUIDIANCT05453838
Bioequivalence of a Diabetes Specific Tube Feed
A study testing oral intake of one serving of the original and new product in people with Postprandial Glucose Response, run by Nutricia Research at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glucose Response
- What is being tested?
- oral intake of one serving of the original and new product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Sep 2022to 29 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- oral intake of one serving of the original and new product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral intake of one serving of the original and new productDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: oral intake of one serving of the original and new product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose - Product A versus Product B
Blood glucose iAUC0-120 [mmol/L*min] [mmol/L]
Measured: 120 minutes
Blood glucose - Product A versus Product B
Blood glucose iCmax [mmol/L] [mmol/L]
Measured: 120 minutes
Secondary outcomes (2)
GI new product
GI = blood glucose iAUC0-120 [mmol/L] of new product / mean blood glucose iAUC0-120 [mmol/L] of reference product
Measured: 120 minutes
GL new product
GL = GI * available carbohydrate/given amount of carbohydrate
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start7 Sep 2022
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial Glucose ResponseStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monique Visser, PhD, Principal investigator, Nutricia Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453838
- Sponsor's protocol ID
- SBB22R&40700
- Acronym
- EQUIDIA
- Status last verified
- Jan 2025
- First submitted
- 7 Jul 2022
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of a Diabetes Specific Tube Feed
- ClinicalTrials.gov ID
- NCT05453838
- Acronym / sponsor ID
- EQUIDIA / SBB22R&40700
- Conditions
- Postprandial Glucose Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New product - Original product | Other | Dietary Supplement: oral intake of one serving of the original and new productAll 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). |
| Original product - New product | Other | Dietary Supplement: oral intake of one serving of the original and new productAll 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral intake of one serving of the original and new product1) 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 | Dietary supplement | New product - Original product, Original product - New product |
Primary outcome
Blood glucose - Product A versus Product B
Time frame: 120 minutes
Blood glucose iAUC0-120 [mmol/L*min] [mmol/L]
Blood glucose - Product A versus Product B
Time frame: 120 minutes
Blood glucose iCmax [mmol/L] [mmol/L]
2 secondary outcomes
GI new product
Time frame: 120 minutes
GL new product
Time frame: 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique Visser, PhD principal investigator
Nutricia Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral intake of one serving of the original and new product in people with Postprandial Glucose Response, run by Nutricia Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose - Product A versus Product B (time frame: 120 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.