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

This study assesses the glycemic responses to several nutritional products.

Study Overview

• Status: Completed
• Conditions: Postprandial Hypoglycemia
• Intervention / Treatment: Dietary supplement: First concept product (containing 50 grams of carbohydrates); Dietary supplement: Second concept product (containing 50 grams of carbohydrates); Dietary supplement: Reference product (containing 50 grams of carbohydrates)

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands
    • EB UtrechtResearch BV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dietary supplement/First concept Product 1 (containing 50 grams of carbohydrates); All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: First concept product (containing 50 grams of carbohydrates); Fasted intake of First concept product (randomised); Dietary supplement: Second concept product (containing 50 grams of carbohydrates); Fasted intake Second concept product (randomised); Dietary supplement: Reference product (containing 50 grams of carbohydrates); Fasted intake of Reference product (randomised)
Active Comparator: Dietary supplement/First concept Product 2 (containing 50 grams of carbohydrates); All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized	Dietary supplement: First concept product (containing 50 grams of carbohydrates); Fasted intake of First concept product (randomised); Dietary supplement: Second concept product (containing 50 grams of carbohydrates); Fasted intake Second concept product (randomised); Dietary supplement: Reference product (containing 50 grams of carbohydrates); Fasted intake of Reference product (randomised)
Active Comparator: Reference product (containing 50 grams of carbohydrates); All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized	Dietary supplement: First concept product (containing 50 grams of carbohydrates); Fasted intake of First concept product (randomised); Dietary supplement: Second concept product (containing 50 grams of carbohydrates); Fasted intake Second concept product (randomised); Dietary supplement: Reference product (containing 50 grams of carbohydrates); Fasted intake of Reference product (randomised)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental Area Under the Curve (iAUC) for glucose	Incremental Area Under the Curve (iAUC) for glucose (mmol/L/hrs)	6 hours
Incremental Area Under the Curve (iAUC) for insulin	Incremental Area Under the Curve (iAUC) for insulin (pmol/L/hrs)	6 hours
Incremental Area Under the Curve (iAUC) for paracetamol	Incremental Area Under the Curve (iAUC) for paracetamol (pmol/L/hrs)	6 hours
Incremental peak levels (iCmax) of glucose	Incremental peak levels (iCmax) of glucose (mmol/L)	6 hours
Incremental peak levels (iCmax) of insulin	Incremental peak levels (iCmax) of insulin (pmol/L)	6 hours
Incremental peak levels (iCmax) of paracetamol	Incremental peak levels (iCmax) of paracetamol (mg/L)	6 hours
Time to peak levels (Tmax) of glucose	Time to peak levels (Tmax) of glucose (min)	6 hours
Time to peak levels (Tmax) of insulin	Time to peak levels (Tmax) of insulin (min)	6 hours
Time to peak levels (Tmax) of paracetamol	Time to peak levels (Tmax) of paracetamol (min)	6 hours

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: carbohydrate metabolism; nutritional product; glucose response
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: SBB22R&52507

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No