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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01734590
First received: November 21, 2012
Last updated: March 5, 2013
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Dietary Supplement: Carbohydrate based food mix 1
Dietary Supplement: Carbohydrate based food mix 2
Dietary Supplement: Control carbohydrate based food

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Different Flour Compositions in a Carbohydrate-based Food on Rate of Exogenous Glucose Appearance in Blood.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique. [ Time Frame: Measured during 360 min for 3 periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total blood glucose and insulin [ Time Frame: Measured during 360 min for 3 periods ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: November 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carbohydrate based food mix 1
Slowly digestible carbohydrate
 Dietary Supplement: Carbohydrate based food mix 2
Carbohydrate based food
Other Name: Slowly digestible carbohydrate
Dietary Supplement: Control carbohydrate based food
Carbohydrate based food
Other Name: Rapidly digestible carbohydrate
Experimental: Carbohydrate based food mix 2
Slowly digestible carbohydrate
 Dietary Supplement: Carbohydrate based food mix 1
Carbohydrate based food
Other Name: Slowly digestible carbohydrate
Dietary Supplement: Control carbohydrate based food
Carbohydrate based food
Other Name: Rapidly digestible carbohydrate
Active Comparator: Control carbohydrate based food
Rapidly digestible carbohydrate
 Dietary Supplement: Carbohydrate based food mix 1
Carbohydrate based food
Other Name: Slowly digestible carbohydrate
Dietary Supplement: Carbohydrate based food mix 2
Carbohydrate based food
Other Name: Slowly digestible carbohydrate

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734590

Locations
Netherlands
QPS
Groningen, Hanzeplein 1, Netherlands, 9713 GZ
Sponsors and Collaborators
Unilever R&D
Investigators
Principal Investigator: Khalid Abd-Elaziz QPS Netherlands BV
  More Information

No publications provided

Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01734590     History of Changes
Other Study ID Numbers: FDS-NAA-0758
Study First Received: November 21, 2012
Last Updated: March 5, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Unilever R&D:
Flour,
carbohydrate,
digestibility
subjects

ClinicalTrials.gov processed this record on May 19, 2013