Healthy
Conditions
Keywords
Flour,, carbohydrate,, digestibility, subjects
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTCarbohydrate based food mix 1
Carbohydrate based food
DIETARY_SUPPLEMENTCarbohydrate based food mix 2
Carbohydrate based food
DIETARY_SUPPLEMENTControl carbohydrate based food
Carbohydrate based food
Sponsors
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique. | Measured during 360 min for 3 periods |
Secondary
| Measure | Time frame |
|---|---|
| Total blood glucose and insulin | Measured during 360 min for 3 periods |
Countries
Netherlands
Outcome results
None listed