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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
  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
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: 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 November 25, 2014