CompletedNot Applicable

Glucose Response to a Formula for Patients at Risk of Hypoglycaemia

Netherlands18 participantsStarted 2023-02-13

Plain-language summary

This study assesses the glycemic responses to several nutritional products.

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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

Decline in glucose level after reaching peak (Cmax)

Timeframe: 6 hours

NCT IDNCT05676385

SponsorNutricia Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-30

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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