Effect of Different Flour Compositions in a Carbohydrate-based Food on Rate of Exogenous Glucose Appearance in Blood

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Different Flour Compositions in a Carbohydrate-based Food on Rate of Exogenous Glucose Appearance in Blood.

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Carbohydrate based food mix 1
* Dietary Supplement: Carbohydrate based food mix 2
* Dietary Supplement: Control carbohydrate based food


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbohydrate based food mix 1<br>Slowly digestible carbohydrate | Dietary Supplement: Carbohydrate based food mix 2<br>* Carbohydrate based food<br>* Other names: Slowly digestible carbohydrate;Dietary Supplement: Control carbohydrate based food<br>* Carbohydrate based food<br>* Other names: Rapidly digestible carbohydrate;|
| Experimental: Carbohydrate based food mix 2<br>Slowly digestible carbohydrate | Dietary Supplement: Carbohydrate based food mix 1<br>* Carbohydrate based food<br>* Other names: Slowly digestible carbohydrate;Dietary Supplement: Control carbohydrate based food<br>* Carbohydrate based food<br>* Other names: Rapidly digestible carbohydrate;|
| Active Comparator: Control carbohydrate based food<br>Rapidly digestible carbohydrate | Dietary Supplement: Carbohydrate based food mix 1<br>* Carbohydrate based food<br>* Other names: Slowly digestible carbohydrate;Dietary Supplement: Carbohydrate based food mix 2<br>* Carbohydrate based food<br>* Other names: Slowly digestible carbohydrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique. |  | Measured during 360 min for 3 periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total blood glucose and insulin |  | Measured during 360 min for 3 periods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flour,, carbohydrate,, digestibility, subjects