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OpenTrials
Completed

NCT Number: NCT05676385

Glucose Response to a Formula for Patients at Risk of Hypoglycaemia

This study assesses the glycemic responses to several nutritional products.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EB UtrechtResearch BV

Utrecht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

First concept product (containing 50 grams of carbohydrates)

Dietary Supplement

Fasted intake of First concept product (randomised)

Second concept product (containing 50 grams of carbohydrates)

Dietary Supplement

Fasted intake Second concept product (randomised)

Reference product (containing 50 grams of carbohydrates)

Dietary Supplement

Fasted intake of Reference product (randomised)

Primary outcomes

  1. Decline in glucose level after reaching peak (Cmax)

    Time frame: 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 outcomes

  1. Incremental Area Under the Curve (iAUC) for glucose

    Time frame: 6 hours

    Incremental Area Under the Curve (iAUC) for glucose (mmol/L/hrs)

  2. Incremental Area Under the Curve (iAUC) for insulin

    Time frame: 6 hours

    Incremental Area Under the Curve (iAUC) for insulin (pmol/L/hrs)

  3. Incremental Area Under the Curve (iAUC) for paracetamol

    Time frame: 6 hours

    Incremental Area Under the Curve (iAUC) for paracetamol (pmol/L/hrs)

  4. Incremental peak levels (iCmax) of glucose

    Time frame: 6 hours

    Incremental peak levels (iCmax) of glucose (mmol/L)

  5. Incremental peak levels (iCmax) of insulin

    Time frame: 6 hours

    Incremental peak levels (iCmax) of insulin (pmol/L)

  6. Incremental peak levels (iCmax) of paracetamol

    Time frame: 6 hours

    Incremental peak levels (iCmax) of paracetamol (mg/L)

  7. Time to peak levels (Tmax) of glucose

    Time frame: 6 hours

    Time to peak levels (Tmax) of glucose (min)

  8. Time to peak levels (Tmax) of insulin

    Time frame: 6 hours

    Time to peak levels (Tmax) of insulin (min)

  9. Time to peak levels (Tmax) of paracetamol

    Time frame: 6 hours

    Time to peak levels (Tmax) of paracetamol (min)

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Acronym: EFFECT

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 9, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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