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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Ensure® Abbott Nutrition; Dietary Supplement: Glucerna® Abbott Nutrition; Dietary Supplement: Diasip® Nutricia Advanced; Dietary Supplement: Glicolab®

• Registration Number: NCT03829800
• Lead Sponsor: Universidad del Zulia

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2017-09-01
• Study Completion: 2018-11-15
• Study First Submitted: 2019-01-28
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-01
• Last Update Submitted: 2019-02-01
• Study First Posted: 2019-02-04
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ensure® Abbott Nutrition	Ensure® Abbott Nutrition	A standard nutritional formula not specific for diabetics
Glucerna® Abbott Nutrition	Glucerna® Abbott Nutrition	A formula with a patented blend of slow-digesting carbohydrates including resistant maltodextrin and sucromalt
Diasip® Nutricia Advanced	Diasip® Nutricia Advanced	A formula whose composition has isomaltulose and resistant starch
Glicolab®	Glicolab®	Glucose solution

Primary Outcome Measures

Name	Time	Method
Change from baseline Glycemia at 180 minutes	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.	mmol/L
Change from baseline Insulin at 180 minutes	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.	milliunits per liter (mU/L)
Glycemic Index (GI)	180 minutes after intake of each formula	Low GI (≤ 55), Intermediate (55-69) and High (≥70)
Glycemic Load (GL)	180 minutes after intake of each formula	High GL (\> 20), Intermediate GL (11-19) and Low GL (\<10)
Change from baseline GLP-1 at 180 minutes	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.	pmol/L
Change from baseline GIP at 180 minutes	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.	pg/mL
Change from baseline Hunger at 180 minutes	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.	Visual Analogue Scale (mm)
Change from baseline Fullness at 180 minutes	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.	Visual Analogue Scale (mm)
Change from baseline Desire to eat at 180 minutes	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.	Visual Analogue Scale (mm)
Change from baseline Subjective appetite at 180 minutes	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.	Visual Analogue Scale (mm)
Change from baseline Prospective food consumption at 180 minutes	Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.	Visual Analogue Scale (mm)

Secondary Outcome Measures

Name	Time	Method
LDL-C	Baseline	mg/dl
HDL-C	Baseline	mg/dl
Age	Baseline	years
Height	Baseline	m
Body Mass Index	Baseline	kg/m\^2
Total Cholesterol	Baseline	mg/dl
Triacylglycerides	Baseline	mg/dl
HbA1c	Baseline	percentage (%)
Weight	Baseline	kg
Hip Circumference	Baseline	cm