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NCT Number: NCT01734590

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

QPS

Groningen, Hanzeplein 1, 9713 GZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Carbohydrate based food mix 1

Dietary Supplement

Carbohydrate based food

Other names: Slowly digestible carbohydrate

Carbohydrate based food mix 2

Dietary Supplement

Carbohydrate based food

Other names: Slowly digestible carbohydrate

Control carbohydrate based food

Dietary Supplement

Carbohydrate based food

Other names: Rapidly digestible carbohydrate

Primary outcomes

  1. Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique.

    Time frame: Measured during 360 min for 3 periods

Secondary outcomes

  1. Total blood glucose and insulin

    Time frame: Measured during 360 min for 3 periods

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 27, 2012
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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