Glucose Response to a Formula for Patients at Risk of Hypoglycaemia

Not Applicable

Completed

• Conditions: Postprandial Hypoglycemia

• Registration Number: NCT05676385
• Lead Sponsor: Nutricia Research

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.

Study Timeline

• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-09
• Study Start: 2023-02-13
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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)
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)
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)

Trial Locations

Locations (1)

EB UtrechtResearch BV; 🇳🇱 Utrecht, Netherlands