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

Nutricia

Status: Completed

Conditions: Postprandial Hypoglycemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05676385

SBB22R&52507

Details and patient eligibility

About

This study assesses the glycemic responses to several nutritional products.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 3 patient groups

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

Active Comparator group

Description:

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

Treatment:

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

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

Dietary Supplement: First concept product (containing 50 grams of carbohydrates)

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

Active Comparator group

Description:

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

Treatment:

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

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

Dietary Supplement: First concept product (containing 50 grams of carbohydrates)

Reference product (containing 50 grams of carbohydrates)

Active Comparator group

Description:

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

Treatment:

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

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

Dietary Supplement: First concept product (containing 50 grams of carbohydrates)