NCT01437917

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

September 20, 2011

Last Update Submit

May 15, 2012

Conditions

Healthy

Keywords

glycemic index

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • AUC for insulinemia for the 2 hours following the ingestion of each bread.

    2 hours

Study Arms (3)

Bread with 20% amylose content

EXPERIMENTAL

Bread with 20% amylose content

Other: 20% amylose bread

Bread with 10% amylose content

EXPERIMENTAL

Bread with 10% amylose content

Dietary Supplement: 10% amylose bread

carbohydrates

EXPERIMENTAL

50g of carbohydrates ingested with 400 ml of water

Dietary Supplement: Carbohydrates

Interventions

20% amylose breadOTHER

20% amylose bread

Bread with 20% amylose content
10% amylose breadDIETARY_SUPPLEMENT

10% amylose bread

Bread with 10% amylose content
CarbohydratesDIETARY_SUPPLEMENT

50g of carbohydrates ingested with 400 ml of water

carbohydrates

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • BMI \> 25 kg/m2,
  • Diabetes or any illness susceptible to alter
  • Coeliac disease
  • Past history of intestinal diseases.
  • Treatment susceptible of modifying glycemia.
  • Allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35033, France

Location

MeSH Terms

Interventions

Carbohydrates

Study Officials

  • Fabrice BONNET, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 21, 2011

Study Start

September 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

FR(1)