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Glucose Response to a Formula for Patients at Risk of Hypoglycaemia (EFFECT)

Primary Purpose

Postprandial Hypoglycemia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
First concept product (containing 50 grams of carbohydrates)
Second concept product (containing 50 grams of carbohydrates)
Reference product (containing 50 grams of carbohydrates)
Sponsored by
Nutricia Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postprandial Hypoglycemia focused on measuring nutritional product, glucose response, carbohydrate metabolism

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • EB UtrechtResearch BV

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Dietary supplement/First concept Product 1 (containing 50 grams of carbohydrates)

Dietary supplement/First concept Product 2 (containing 50 grams of carbohydrates)

Reference product (containing 50 grams of carbohydrates)

Arm Description

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized

Outcomes

Primary Outcome Measures

Decline in glucose level after reaching peak (Cmax)
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

Incremental Area Under the Curve (iAUC) for glucose
Incremental Area Under the Curve (iAUC) for glucose (mmol/L/hrs)
Incremental Area Under the Curve (iAUC) for insulin
Incremental Area Under the Curve (iAUC) for insulin (pmol/L/hrs)
Incremental Area Under the Curve (iAUC) for paracetamol
Incremental Area Under the Curve (iAUC) for paracetamol (pmol/L/hrs)
Incremental peak levels (iCmax) of glucose
Incremental peak levels (iCmax) of glucose (mmol/L)
Incremental peak levels (iCmax) of insulin
Incremental peak levels (iCmax) of insulin (pmol/L)
Incremental peak levels (iCmax) of paracetamol
Incremental peak levels (iCmax) of paracetamol (mg/L)
Time to peak levels (Tmax) of glucose
Time to peak levels (Tmax) of glucose (min)
Time to peak levels (Tmax) of insulin
Time to peak levels (Tmax) of insulin (min)
Time to peak levels (Tmax) of paracetamol
Time to peak levels (Tmax) of paracetamol (min)

Full Information

First Posted
December 12, 2022
Last Updated
June 20, 2023
Sponsor
Nutricia Research
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1. Study Identification

Unique Protocol Identification Number
NCT05676385
Brief Title
Glucose Response to a Formula for Patients at Risk of Hypoglycaemia
Acronym
EFFECT
Official Title
Glucose Response to a Formula for Patients at Risk of Hypoglycaemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutricia Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hypoglycemia
Keywords
nutritional product, glucose response, carbohydrate metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomised, controlled, double-blind, cross-over, single-centre, Proof of-Concept study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary supplement/First concept Product 1 (containing 50 grams of carbohydrates)
Arm Type
Active Comparator
Arm Description
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm Title
Dietary supplement/First concept Product 2 (containing 50 grams of carbohydrates)
Arm Type
Active Comparator
Arm Description
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized
Arm Title
Reference product (containing 50 grams of carbohydrates)
Arm Type
Active Comparator
Arm Description
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized
Intervention Type
Dietary Supplement
Intervention Name(s)
First concept product (containing 50 grams of carbohydrates)
Intervention Description
Fasted intake of First concept product (randomised)
Intervention Type
Dietary Supplement
Intervention Name(s)
Second concept product (containing 50 grams of carbohydrates)
Intervention Description
Fasted intake Second concept product (randomised)
Intervention Type
Dietary Supplement
Intervention Name(s)
Reference product (containing 50 grams of carbohydrates)
Intervention Description
Fasted intake of Reference product (randomised)
Primary Outcome Measure Information:
Title
Decline in glucose level after reaching peak (Cmax)
Description
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.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Incremental Area Under the Curve (iAUC) for glucose
Description
Incremental Area Under the Curve (iAUC) for glucose (mmol/L/hrs)
Time Frame
6 hours
Title
Incremental Area Under the Curve (iAUC) for insulin
Description
Incremental Area Under the Curve (iAUC) for insulin (pmol/L/hrs)
Time Frame
6 hours
Title
Incremental Area Under the Curve (iAUC) for paracetamol
Description
Incremental Area Under the Curve (iAUC) for paracetamol (pmol/L/hrs)
Time Frame
6 hours
Title
Incremental peak levels (iCmax) of glucose
Description
Incremental peak levels (iCmax) of glucose (mmol/L)
Time Frame
6 hours
Title
Incremental peak levels (iCmax) of insulin
Description
Incremental peak levels (iCmax) of insulin (pmol/L)
Time Frame
6 hours
Title
Incremental peak levels (iCmax) of paracetamol
Description
Incremental peak levels (iCmax) of paracetamol (mg/L)
Time Frame
6 hours
Title
Time to peak levels (Tmax) of glucose
Description
Time to peak levels (Tmax) of glucose (min)
Time Frame
6 hours
Title
Time to peak levels (Tmax) of insulin
Description
Time to peak levels (Tmax) of insulin (min)
Time Frame
6 hours
Title
Time to peak levels (Tmax) of paracetamol
Description
Time to peak levels (Tmax) of paracetamol (min)
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
EB UtrechtResearch BV
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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Glucose Response to a Formula for Patients at Risk of Hypoglycaemia

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