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NOMAC : New Tools for Managing the Fate of Cereal Nutrients in the Gut : Effects of Amylose Content on Glycemic Index.

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Recherche Agronomique
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01437917
First received: September 20, 2011
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

The consumption of cereals-based foods with low glycemic indexes, high micronutrients and fibers contents are highly recommended. The target of this work is to provide new solutions for cereal based foods: the knowledge and understanding on the in vivo fate will be used to define structural features to gain in foods.


Condition Intervention
Healthy
 Other: 20% amylose bread
Dietary Supplement: 10% amylose bread
Dietary Supplement: Carbohydrates

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: NOMAC : New Tools for Managing the Fate of Cereal Nutrients in the Gut : Effects of Amylose Content on Glycemic Index.

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Glycemic index for each bread [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    To compare the glycemic index of breads made with different amylose content. (S1 to S6) A total of 6 visits. In each visit, blood samples will be taken for measurement of glycemia and insulinemia over 2 hours after ingestion of 50 of carbohydrates ingested with 400 ml of water.


Secondary Outcome Measures:
  • AUC for insulinemia for the 2 hours following the ingestion of each bread. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    To compare the AUC for insulinemia for the 2 hours following the ingestion of each bread.


Enrollment: 10
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bread with 20% amylose content
Bread with 20% amylose content
 Other: 20% amylose bread
20% amylose bread
Experimental: Bread with 10% amylose content
Bread with 10% amylose content
 Dietary Supplement: 10% amylose bread
10% amylose bread
Experimental: carbohydrates
50g of carbohydrates ingested with 400 ml of water
 Dietary Supplement: Carbohydrates
50g of carbohydrates ingested with 400 ml of water

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy individual,
  • Age between 19-65 years
  • With normal food habits with at least 2 main meals per day
  • Non smoking
  • Having filled the consent form

Exclusion Criteria:

  • BMI > 25 kg/m2,
  • Diabetes or any illness susceptible to alter
  • Coeliac disease
  • Past history of intestinal diseases.
  • Treatment susceptible of modifying glycemia.
  • Allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437917

Locations
France
Rennes University Hospital
Rennes, Bretagne, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Institut National de la Recherche Agronomique
Investigators
Principal Investigator: Fabrice BONNET, MD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01437917     History of Changes
Other Study ID Numbers: LOC/11-05 - NOMAC, 2011-A00517-34, 11/19-808, B110607-50
Study First Received: September 20, 2011
Last Updated: May 15, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Rennes University Hospital:
glycemic index

ClinicalTrials.gov processed this record on May 21, 2013