Glucose Response to a Formula for Patients at Risk of Hypoglycaemia

Study Overview
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Brief Summary
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This study assesses the glycemic responses to several nutritional products.

Detailed Description
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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.

Official Title
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Glucose Response to a Formula for Patients at Risk of Hypoglycaemia

Conditions
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Postprandial Hypoglycemia

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomised, controlled, double-blind, cross-over, single-centre, Proof of-Concept study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary supplement/First concept Product 1 (containing 50 grams of carbohydrates)<br>All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. | Dietary Supplement: First concept product (containing 50 grams of carbohydrates)<br>* Fasted intake of First concept product (randomised)<br>Dietary Supplement: Second concept product (containing 50 grams of carbohydrates)<br>* Fasted intake Second concept product (randomised)<br>Dietary Supplement: Reference product (containing 50 grams of carbohydrates)<br>* Fasted intake of Reference product (randomised)<br>|
| Active Comparator: Dietary supplement/First concept Product 2 (containing 50 grams of carbohydrates)<br>All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized | Dietary Supplement: First concept product (containing 50 grams of carbohydrates)<br>* Fasted intake of First concept product (randomised)<br>Dietary Supplement: Second concept product (containing 50 grams of carbohydrates)<br>* Fasted intake Second concept product (randomised)<br>Dietary Supplement: Reference product (containing 50 grams of carbohydrates)<br>* Fasted intake of Reference product (randomised)<br>|
| Active Comparator: Reference product (containing 50 grams of carbohydrates)<br>All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized | Dietary Supplement: First concept product (containing 50 grams of carbohydrates)<br>* Fasted intake of First concept product (randomised)<br>Dietary Supplement: Second concept product (containing 50 grams of carbohydrates)<br>* Fasted intake Second concept product (randomised)<br>Dietary Supplement: Reference product (containing 50 grams of carbohydrates)<br>* Fasted intake of Reference product (randomised)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Area Under the Curve (iAUC) for glucose | Incremental Area Under the Curve (iAUC) for glucose (mmol/L/hrs) | 6 hours | 
| Incremental Area Under the Curve (iAUC) for insulin | Incremental Area Under the Curve (iAUC) for insulin (pmol/L/hrs) | 6 hours | 
| Incremental Area Under the Curve (iAUC) for paracetamol | Incremental Area Under the Curve (iAUC) for paracetamol (pmol/L/hrs) | 6 hours | 
| Incremental peak levels (iCmax) of glucose | Incremental peak levels (iCmax) of glucose (mmol/L) | 6 hours | 
| Incremental peak levels (iCmax) of insulin | Incremental peak levels (iCmax) of insulin (pmol/L) | 6 hours | 
| Incremental peak levels (iCmax) of paracetamol | Incremental peak levels (iCmax) of paracetamol (mg/L) | 6 hours | 
| Time to peak levels (Tmax) of glucose | Time to peak levels (Tmax) of glucose (min) | 6 hours | 
| Time to peak levels (Tmax) of insulin | Time to peak levels (Tmax) of insulin (min) | 6 hours | 
| Time to peak levels (Tmax) of paracetamol | Time to peak levels (Tmax) of paracetamol (min) | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutritional product, glucose response, carbohydrate metabolism