Formulas for Diabetes With Sucromalt & Isomaltulose on Glycemic Index, Hormones & Subjective Appetite in Type 2 Diabetes

Universidad del Zulia

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Glucerna® Abbott Nutrition; Dietary Supplement: Glicolab®; Dietary Supplement: Diasip® Nutricia Advanced; Dietary Supplement: Ensure® Abbott Nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT03829800

1001092016

Details and patient eligibility

About

Consumption of nutritional supplements with low glycemic carbohydrates induce favorable glycemic responses in subjects with type 2 diabetes. The aim of this study was to compare the effect of the intake of specific formulas for diabetes, with different types of carbohydrates (isomaltulose and sucromaltose) on the glycemic response, release of intestinal peptides and subjective appetite in Type 2 diabetic individuals. In a randomized, double-blind, cross-over study of 4 treatments, 16 subjects (56.60 ± 1.11 years). Fasting blood samples were taking, after that they were given to consume formula or reference product assigned randomly. Subsequently, samples of capillary and venous blood were obtained at times 30, 60, 90, 120 and 180 min, after the start of consumption of the experimental beverage for the measurement of glucose, insulin, gastric inhibitory peptide (GIP) and glucagon-like peptide-1 (GLP-1). The assessment of subjective appetite was measured by Visual Analogue Scale (VAS).

Full description

This was a randomized, double-blind, cross-over study of 4 treatments that was conducted according to the Good Clinical Practice Guidelines, with all applicable Food and Drug privacy regulations, and ethical principles based on the Declaration of Helsinki. Participants signed informed consent, approved by the Human Research Ethics Committee of the Endocrine-Metabolic Research Center of the University of Zulia, in Venezuela. All selected subjects attended a first visit, in order to determine if they met the inclusion criteria, those who gathered them, were subjected to four consumption tests to determine the glycemic index (GI) and glycemic load (GL) and 3 consumption tests for the evaluation of subjective appetite. Each treatment or consumption session was carried out on different days.

Enrollment: 23 patients

Sex: All

Ages: 51 to 63 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 Diabetes
• Demonstrated use of oral hypoglycemic agents (metformin), for at least two months
• BMI of 18.5 kg/m2 to ≤ 35 kg/m2

Exclusion criteria

• Type 1 Diabetes
• Diabetic ketoacidosis
• Congestive heart failure
• Gastric, renal or hepatic diseases
• Myocardial infarction
• Stroke
• Subjects with insulin therapy, antibiotic therapy or corticosteroids
• End-stage organ failure
• Individuals with organ transplantation
• Coagulation or bleeding disorder
• Infectious or chronic contagious disease (such as tuberculosis, hepatitis B or C or HIV).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 4 patient groups

Ensure® Abbott Nutrition

Experimental group

Description:

A standard nutritional formula not specific for diabetics

Treatment:

Dietary Supplement: Ensure® Abbott Nutrition

Glucerna® Abbott Nutrition

Experimental group

Description:

A formula with a patented blend of slow-digesting carbohydrates including resistant maltodextrin and sucromalt

Treatment:

Dietary Supplement: Glucerna® Abbott Nutrition

Diasip® Nutricia Advanced

Experimental group

Description:

A formula whose composition has isomaltulose and resistant starch

Treatment:

Dietary Supplement: Diasip® Nutricia Advanced

Glicolab®

Active Comparator group

Description:

Glucose solution

Treatment:

Dietary Supplement: Glicolab®