Effect of Different Flour Compositions in a Carbohydrate-based Food on Rate of Exogenous Glucose Appearance in Blood
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Details and patient eligibility
About
Exploratory study with double-blind, randomized, placebo-controlled, full cross-over design.
The main objective is to identify one or two flour compositions in a carbohydrate-based food that produce a significant difference (alpha =0.2) in the time to reach 50% of cumulative absorption of exogenous glucose compared to the control.
Full description
Twelve volunteers will participate in the study; each person will be studied on three different occasions at least one week apart, consuming the three different test products in a randomized order. Test products are carbohydrate-based food made from different flour mixes differing in their expected rate of intestinal starch digestion. The products are labeled with 13C starch.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
- healthy males
- Age at start of the study ≥18 and ≤ 50 years
- Not smoking
- Body mass index (BMI) ≥ 20 and ≤ 28 kg/m2
- Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening
Trial design
Primary purpose
Allocation
Interventional model
Masking
12 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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