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: June 18, 2013
Last verified: June 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 18, 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 July 29, 2014