EFFECT: Glucose Response to a Formula for Patients at Risk of Hypoglycaemia
Study Details
Study Description
Brief Summary
This study assesses the glycemic responses to several nutritional products.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Dietary supplement/First concept Product 1 (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 (containing 50 grams of carbohydrates)
Fasted intake of First concept product (randomised)
Dietary Supplement: Second concept product (containing 50 grams of carbohydrates)
Fasted intake Second concept product (randomised)
Dietary Supplement: Reference product (containing 50 grams of carbohydrates)
Fasted intake of Reference product (randomised)
|
| Active Comparator: Dietary supplement/First concept Product 2 (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 (containing 50 grams of carbohydrates)
Fasted intake of First concept product (randomised)
Dietary Supplement: Second concept product (containing 50 grams of carbohydrates)
Fasted intake Second concept product (randomised)
Dietary Supplement: Reference product (containing 50 grams of carbohydrates)
Fasted intake of Reference product (randomised)
|
| Active Comparator: 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 (containing 50 grams of carbohydrates)
Fasted intake of First concept product (randomised)
Dietary Supplement: Second concept product (containing 50 grams of carbohydrates)
Fasted intake Second concept product (randomised)
Dietary Supplement: Reference product (containing 50 grams of carbohydrates)
Fasted intake of Reference product (randomised)
|
Outcome Measures
Primary Outcome Measures
- Decline in glucose level after reaching peak (Cmax) [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.
Secondary Outcome Measures
- Incremental Area Under the Curve (iAUC) for glucose [6 hours]
Incremental Area Under the Curve (iAUC) for glucose (mmol/L/hrs)
- Incremental Area Under the Curve (iAUC) for insulin [6 hours]
Incremental Area Under the Curve (iAUC) for insulin (pmol/L/hrs)
- Incremental Area Under the Curve (iAUC) for paracetamol [6 hours]
Incremental Area Under the Curve (iAUC) for paracetamol (pmol/L/hrs)
- Incremental peak levels (iCmax) of glucose [6 hours]
Incremental peak levels (iCmax) of glucose (mmol/L)
- Incremental peak levels (iCmax) of insulin [6 hours]
Incremental peak levels (iCmax) of insulin (pmol/L)
- Incremental peak levels (iCmax) of paracetamol [6 hours]
Incremental peak levels (iCmax) of paracetamol (mg/L)
- Time to peak levels (Tmax) of glucose [6 hours]
Time to peak levels (Tmax) of glucose (min)
- Time to peak levels (Tmax) of insulin [6 hours]
Time to peak levels (Tmax) of insulin (min)
- Time to peak levels (Tmax) of paracetamol [6 hours]
Time to peak levels (Tmax) of paracetamol (min)
Eligibility Criteria
Criteria
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
- 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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Nutricia Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SBB22R&52507