Glucose Response to a Formula for Patients at Risk of Hypoglycaemia

NCT05676385 | Completed

• 1 other identifier: SBB22R&52507
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses the glycemic responses to several nutritional products.

Conditions

Postprandial Hypoglycemia

Keywords

nutritional product; glucose response; carbohydrate metabolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Incremental Area Under the Curve (iAUC) for glucose

  6 hours

• Incremental Area Under the Curve (iAUC) for insulin

  6 hours

• Incremental Area Under the Curve (iAUC) for paracetamol

  6 hours

• Incremental peak levels (iCmax) of glucose

  6 hours

• Incremental peak levels (iCmax) of insulin

  6 hours

Study Arms (3)

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

ACTIVE COMPARATOR

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); Dietary Supplement: Second concept product (containing 50 grams of carbohydrates); Dietary Supplement: Reference product (containing 50 grams of carbohydrates)

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

ACTIVE COMPARATOR

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); Dietary Supplement: Second concept product (containing 50 grams of carbohydrates); Dietary Supplement: Reference product (containing 50 grams of carbohydrates)

Reference product (containing 50 grams of carbohydrates)

ACTIVE COMPARATOR

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); Dietary Supplement: Second concept product (containing 50 grams of carbohydrates); Dietary Supplement: Reference product (containing 50 grams of carbohydrates)

Interventions

First concept product (containing 50 grams of carbohydrates) DIETARY_SUPPLEMENT

Fasted intake of First concept product (randomised)

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)

Second concept product (containing 50 grams of carbohydrates) DIETARY_SUPPLEMENT

Fasted intake Second concept product (randomised)

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)

Reference product (containing 50 grams of carbohydrates) DIETARY_SUPPLEMENT

Fasted intake of Reference product (randomised)

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)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

EB UtrechtResearch BV

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, controlled, double-blind, cross-over, single-centre, Proof of-Concept study

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 9, 2023
• Study Start: February 13, 2023
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)