The goal of this mechanistic, exploratory study is to compare the effectiveness of Oligomalt to Glucidex 40 after eating in adults with Type 2 Diabetes (T2D) and in otherwise healthy adults with overweight or obesity (HAO).
The main question it aims to answer is how consumption of Oligomalt, a slowly digestible carbohydrate, will reduce glucose and insulin spikes in adults with T2D and in HAO relative to Glucidex 40.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
44
The investigational product (Oligomalt) dissolved in 300 ml water will be consumed over approximately 10 minutes in the morning of the study visit after a fasting period of at least 10 hours.
The investigational product (maltodextrin) dissolved in 300 ml water will be consumed over approximately 10 minutes in the morning of the study visit after a fasting period of at least 10 hours.
Orange County Research Center
Tustin, California, United States
Incremental area under the curve (iAUC) of post-prandial glycemic excursion induced by Oligomalt relative to maltodextrin over the observation period: iAUC 0-1 hour, iAUC 0-2 hours, iAUC 0-3 hours.
Comparisons in the T2D group: 50 g Oligomalt vs 50 g Glucidex 40. Comparisons in the HAO group: 33 g Oligomalt vs 33 g Glucidex 40 and 50 g Oligomalt vs 50 g Glucidex 40.
Time frame: Over the course of 3 hours following study product intake
Total blood glucose AUC
Time frame: Over the course of 3 hours following study product intake
Blood glucose (iCmax)
Maximum blood glucose level
Time frame: Over the course of 3 hours following study product intake
Blood glucose (Cmin)
Minimum blood glucose level
Time frame: Over the course of 3 hours following study product intake
Blood glucose (Tmax)
Time point at which maximum blood glucose level is measured
Time frame: Over the course of 3 hours following study product intake
Blood glucose (Tmin)
Time point at which minimum blood glucose level is measured
Time frame: Over the course of 3 hours following study product intake
Number of participants with glucose levels less than or equal to 3.9 mmol/L
Time frame: Over the course of 3 hours following study product intake
Number of participants with glucose levels less than or equal to 3.1 mmol/L
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Time frame: Over the course of 3 hours following study product intake
Serum insulin level
Time frame: Over the course of 3 hours following study product intake
Insulinogenic index (IGI)
A measure of early β-cell capacity (first- phase insulin response)
Time frame: 30 minutes
Insulin index
Time frame: Over the course of 2 hours following study product intake
Matsuda Index (MI)
Time frame: Over the course of 2 hours following study product intake
Plasma glucagon-like peptide 1 (GLP-1)
Time frame: Over the course of up to 3 hours following study product intake
Plasma peptide tyrosine (PYY)
Time frame: Over the course of up to 3 hours following study product intake