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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: 20% amylose bread; Dietary supplement: 10% amylose bread; Dietary supplement: Carbohydrates

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35033
      • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bread with 20% amylose content	Other: 20% amylose bread; 20% amylose bread
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic index for each bread	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.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC for insulinemia for the 2 hours following the ingestion of each bread.	To compare the AUC for insulinemia for the 2 hours following the ingestion of each bread.	2 hours

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: Institut National de la Recherche Agronomique
• Investigators: Principal Investigator: Fabrice BONNET, MD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: September 20, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (Estimate): September 21, 2011

Study Record Updates

• Last Update Posted (Estimate): May 16, 2012
• Last Update Submitted That Met QC Criteria: May 15, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: glycemic index
• Other Study ID Numbers: LOC/11-05 - NOMAC; 2011-A00517-34 (Other Identifier: ID RCB); 11/19-808 (Other Identifier: CPP Ouest V); B110607-50 (Other Identifier: AFSSAPS)