Postprandial Hypoglycemia
Conditions
Keywords
nutritional product, glucose response, carbohydrate metabolism
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTFirst concept product (containing 50 grams of carbohydrates)
Fasted intake of First concept product (randomised)
DIETARY_SUPPLEMENTSecond concept product (containing 50 grams of carbohydrates)
Fasted intake Second concept product (randomised)
DIETARY_SUPPLEMENTReference product (containing 50 grams of carbohydrates)
Fasted intake of Reference product (randomised)
Sponsors
Nutricia Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomised, controlled, double-blind, cross-over, single-centre, Proof of-Concept study
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy individuals, 18 up to and including 50 years of age. 2. Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial. 3. Willing to avoid the consumption of alcohol, unusual food intake, unusual physical activity 24h prior to each study visit. 4. 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
1. Blood glucose levels ≥ 7.8 mmol/L at screening (not fasted) 2. 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. 3. 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. 4. Use of medications known to influence gastric emptying (including but not limited to anticholinergics, nicotine, narcotic analgesics, ganglion blocking drugs, antacids and metoclopramide). 5. Use of anti-clotting medications. 6. 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). 7. Self-reported pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Area Under the Curve (iAUC) for glucose | 6 hours | Incremental Area Under the Curve (iAUC) for glucose (mmol/L/hrs) |
| 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) |
| Incremental peak levels (iCmax) of paracetamol | 6 hours | Incremental peak levels (iCmax) of paracetamol (mg/L) |
Countries
Netherlands
Outcome results
None listed