Postprandial HypoglycemiaEFFECTNCT05676385
Glucose Response to a Formula for Patients at Risk of Hypoglycaemia
A study testing First concept product (containing 50 grams of carbohydrates), Second concept product (containing 50 grams of carbohydrates) and Reference product (containing 50 grams of carbohydrates) in people with Postprandial Hypoglycemia, run by Nutricia Research at 1 site in Netherlands.
Trial summary
This study assesses the glycemic responses to several nutritional products. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hypoglycemia
- What is being tested?
- First concept product (containing 50 grams of carbohydrates), Second concept product (containing 50 grams of carbohydrates) and Reference product (containing 50 grams of carbohydrates)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Feb 2023to 30 Mar 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals, 18 up to and including 50 years of age.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Willing to avoid the consumption of alcohol, unusual food intake, unusual physical activity 24h prior to each study visit.
- Willing to come to the study visit in the morning after an overnight fast of minimum 10 hours and maximum 14 hours (with water only).
Who cannot join
- Blood glucose levels ≥ 7.8 mmol/L at screening (not fasted)
- Known history of gastrointestinal disease (e.g., diverticulitis, Crohn's disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the Principal Investigator either: 1) make participation dangerous to the subject (e.g. anaemia) or to others, or 2) affect the results.
- Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the Principal Investigator either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Use of medications known to influence gastric emptying (including but not limited to anticholinergics, nicotine, narcotic analgesics, ganglion blocking drugs, antacids and metoclopramide).
- Use of anti-clotting medications.
- Current tobacco smokers or smokers that quite smoking < 1 month prior to screening (except for occasional (≤ 3) cigarettes/cigars/pipes per week on average over the past month).
- Self-reported pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
This study assesses the glycemic responses to several nutritional products.
Read the detailed description
During a study visit fasted subjects will consume one serving of the reference product or of the test products. Venous blood samples will be taken at baseline and at several time-points over a 6-hr period.
- Conditions
- Postprandial Hypoglycemia
- Being tested
- First concept product (containing 50 grams of carbohydrates), Second concept product (containing 50 grams of carbohydrates), Reference product (containing 50 grams of carbohydrates)
- Keywords
- nutritional product, glucose response, carbohydrate metabolism
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First concept product (containing 50 grams of carbohydrates)Dietary supplement
Fasted intake of First concept product (randomised)
Second concept product (containing 50 grams of carbohydrates)Dietary supplement
Fasted intake Second concept product (randomised)
Reference product (containing 50 grams of carbohydrates)Dietary supplement
Fasted intake of Reference product (randomised)
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement/First concept Product 1 (containing 50 grams of carbohydrates) | Active comparator | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. Receives: Dietary Supplement: First concept product (containing 50 grams of carbohydrates); Dietary Supplement: Second concept product (containing 50 grams of carbohydrates); Dietary Supplement: Reference product (containing 50 grams of carbohydrates) |
| Dietary supplement/First concept Product 2 (containing 50 grams of carbohydrates) | Active comparator | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized Receives: Dietary Supplement: First concept product (containing 50 grams of carbohydrates); Dietary Supplement: Second concept product (containing 50 grams of carbohydrates); Dietary Supplement: Reference product (containing 50 grams of carbohydrates) |
| Reference product (containing 50 grams of carbohydrates) | Active comparator | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized Receives: Dietary Supplement: First concept product (containing 50 grams of carbohydrates); Dietary Supplement: Second concept product (containing 50 grams of carbohydrates); Dietary Supplement: Reference product (containing 50 grams of carbohydrates) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline in glucose level after reaching peak (Cmax)
The decline in glucose (mmol/hour) after reaching peak glucose levels (Cmax) until reaching baseline (t = -5) blood glucose levels or, in case baseline blood glucose levels are not reached, the lowest observed blood glucose level.
Measured: 6 hours
Secondary outcomes (9)
Incremental Area Under the Curve (iAUC) for glucose
Incremental Area Under the Curve (iAUC) for glucose (mmol/L/hrs)
Measured: 6 hours
Incremental Area Under the Curve (iAUC) for insulin
Incremental Area Under the Curve (iAUC) for insulin (pmol/L/hrs)
Measured: 6 hours
Incremental Area Under the Curve (iAUC) for paracetamol
Incremental Area Under the Curve (iAUC) for paracetamol (pmol/L/hrs)
Measured: 6 hours
Incremental peak levels (iCmax) of glucose
Incremental peak levels (iCmax) of glucose (mmol/L)
Measured: 6 hours
Incremental peak levels (iCmax) of insulin
Incremental peak levels (iCmax) of insulin (pmol/L)
Measured: 6 hours
Incremental peak levels (iCmax) of paracetamol
Incremental peak levels (iCmax) of paracetamol (mg/L)
Measured: 6 hours
Time to peak levels (Tmax) of glucose
Time to peak levels (Tmax) of glucose (min)
Measured: 6 hours
Time to peak levels (Tmax) of insulin
Time to peak levels (Tmax) of insulin (min)
Measured: 6 hours
Time to peak levels (Tmax) of paracetamol
Time to peak levels (Tmax) of paracetamol (min)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start13 Feb 2023
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HypoglycemiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, controlled, double-blind, cross-over, single-centre, Proof of-Concept study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676385
- Sponsor's protocol ID
- SBB22R&52507
- Acronym
- EFFECT
- Status last verified
- Jun 2023
- First submitted
- 12 Dec 2022
- Last updated
- 22 Jun 2023
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Response to a Formula for Patients at Risk of Hypoglycaemia
- ClinicalTrials.gov ID
- NCT05676385
- Acronym / sponsor ID
- EFFECT / SBB22R&52507
- Conditions
- Postprandial Hypoglycemia
- Keywords
- nutritional product, glucose response, carbohydrate metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 9 Jan 2023 (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.
This study assesses the glycemic responses to several nutritional products.
Detailed description
During a study visit fasted subjects will consume one serving of the reference product or of the test products. Venous blood samples will be taken at baseline and at several time-points over a 6-hr period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomised, controlled, double-blind, cross-over, single-centre, Proof of-Concept study
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement/First concept Product 1 (containing 50 grams of carbohydrates) | Active comparator | Dietary Supplement: First concept product (containing 50 grams of carbohydrates), Dietary Supplement: Second concept product (containing 50 grams of carbohydrates), Dietary Supplement: Reference product (containing 50 grams of carbohydrates)All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| Dietary supplement/First concept Product 2 (containing 50 grams of carbohydrates) | Active comparator | Dietary Supplement: First concept product (containing 50 grams of carbohydrates), Dietary Supplement: Second concept product (containing 50 grams of carbohydrates), Dietary Supplement: Reference product (containing 50 grams of carbohydrates)All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized |
| Reference product (containing 50 grams of carbohydrates) | Active comparator | Dietary Supplement: First concept product (containing 50 grams of carbohydrates), Dietary Supplement: Second concept product (containing 50 grams of carbohydrates), Dietary Supplement: Reference product (containing 50 grams of carbohydrates)All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy individuals, 18 up to and including 50 years of age.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Willing to avoid the consumption of alcohol, unusual food intake, unusual physical activity 24h prior to each study visit.
- Willing to come to the study visit in the morning after an overnight fast of minimum 10 hours and maximum 14 hours (with water only).
Key exclusion criteria (7 listed)
- Blood glucose levels ≥ 7.8 mmol/L at screening (not fasted)
- Known history of gastrointestinal disease (e.g., diverticulitis, Crohn's disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the Principal Investigator either: 1) make participation dangerous to the subject (e.g. anaemia) or to others, or 2) affect the results.
- Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the Principal Investigator either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Use of medications known to influence gastric emptying (including but not limited to anticholinergics, nicotine, narcotic analgesics, ganglion blocking drugs, antacids and metoclopramide).
- Use of anti-clotting medications.
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 |
|---|---|---|
| First concept product (containing 50 grams of carbohydrates)Fasted intake of First concept product (randomised) | Dietary supplement | Dietary supplement/First concept Product 1 (containing 50 grams of carbohydrates), Dietary supplement/First concept Product 2 (containing 50 grams of carbohydrates), Reference product (containing 50 grams of carbohydrates) |
| Second concept product (containing 50 grams of carbohydrates)Fasted intake Second concept product (randomised) | Dietary supplement | Dietary supplement/First concept Product 1 (containing 50 grams of carbohydrates), Dietary supplement/First concept Product 2 (containing 50 grams of carbohydrates), Reference product (containing 50 grams of carbohydrates) |
| Reference product (containing 50 grams of carbohydrates)Fasted intake of Reference product (randomised) | Dietary supplement | Dietary supplement/First concept Product 1 (containing 50 grams of carbohydrates), Dietary supplement/First concept Product 2 (containing 50 grams of carbohydrates), Reference product (containing 50 grams of carbohydrates) |
Primary outcome
Decline in glucose level after reaching peak (Cmax)
Time frame: 6 hours
The decline in glucose (mmol/hour) after reaching peak glucose levels (Cmax) until reaching baseline (t = -5) blood glucose levels or, in case baseline blood glucose levels are not reached, the lowest observed blood glucose level.
9 secondary outcomes
Incremental Area Under the Curve (iAUC) for glucose
Time frame: 6 hours
Incremental Area Under the Curve (iAUC) for insulin
Time frame: 6 hours
Incremental Area Under the Curve (iAUC) for paracetamol
Time frame: 6 hours
Incremental peak levels (iCmax) of glucose
Time frame: 6 hours
Incremental peak levels (iCmax) of insulin
Time frame: 6 hours
Incremental peak levels (iCmax) of paracetamol
Time frame: 6 hours
Time to peak levels (Tmax) of glucose
Time frame: 6 hours
Time to peak levels (Tmax) of insulin
Time frame: 6 hours
Time to peak levels (Tmax) of paracetamol
Time frame: 6 hours
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 22 Jun 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First concept product (containing 50 grams of carbohydrates), Second concept product (containing 50 grams of carbohydrates) and Reference product (containing 50 grams of carbohydrates) in people with Postprandial Hypoglycemia, 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 4 inclusion and 7 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 22 Jun 2023. 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?
Decline in glucose level after reaching peak (Cmax) (time frame: 6 hours). 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 22 Jun 2023.