Clinical trial NCT05676385: Glucose Response to a Formula for Patients at Risk of Hypoglycaemia
Official title: Glucose Response to a Formula for Patients at Risk of Hypoglycaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hypoglycemia
Keywords: nutritional product
glucose response
carbohydrate metabolism
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2023-01-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, controlled, double-blind, cross-over, single-centre, Proof of-Concept study
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decline in glucose level after reaching peak (Cmax)
timeFrame: 6 hours
Secondary outcomes:
measure: Incremental Area Under the Curve (iAUC) for glucose
timeFrame: 6 hours
measure: Incremental Area Under the Curve (iAUC) for insulin
timeFrame: 6 hours
measure: Incremental Area Under the Curve (iAUC) for paracetamol
timeFrame: 6 hours
measure: Incremental peak levels (iCmax) of glucose
timeFrame: 6 hours
measure: Incremental peak levels (iCmax) of insulin
timeFrame: 6 hours
measure: Incremental peak levels (iCmax) of paracetamol
timeFrame: 6 hours
measure: Time to peak levels (Tmax) of glucose
timeFrame: 6 hours
measure: Time to peak levels (Tmax) of insulin
timeFrame: 6 hours
measure: Time to peak levels (Tmax) of paracetamol
timeFrame: 6 hours
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: EB UtrechtResearch BV
Study officials:
References: