HealthyNOMACNCT01437917
NOMAC : New Tools for Managing the Fate of Cereal Nutrients in the Gut : Effects of Amylose Content on Glycemic Index.
A study testing 20% amylose bread, 10% amylose bread and Carbohydrates in people with Healthy, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 20% amylose bread, 10% amylose bread and Carbohydrates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- BMI > 25 kg/m2,
- Diabetes or any illness susceptible to alter
- Coeliac disease
- Past history of intestinal diseases.
- Treatment susceptible of modifying glycemia.
- Allergy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- 20% amylose bread, 10% amylose bread, Carbohydrates
- Keywords
- glycemic index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% amylose breadOther
20% amylose bread
10% amylose breadDietary supplement
10% amylose bread
CarbohydratesDietary supplement
50g of carbohydrates ingested with 400 ml of water
| Study group | Role | What they receive |
|---|---|---|
| Bread with 20% amylose content | Experimental | Bread with 20% amylose content Receives: Other: 20% amylose bread |
| Bread with 10% amylose content | Experimental | Bread with 10% amylose content Receives: Dietary Supplement: 10% amylose bread |
| carbohydrates | Experimental | 50g of carbohydrates ingested with 400 ml of water Receives: Dietary Supplement: Carbohydrates |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (1)
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Responsible party
- Sponsor
- Investigators
- Fabrice BONNET, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437917
- Sponsor's protocol ID
- LOC/11-05 - NOMAC
- Other IDs
- 2011-A00517-34, 11/19-808, B110607-50
- Acronym
- NOMAC
- Status last verified
- May 2012
- First submitted
- 20 Sep 2011
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOMAC : New Tools for Managing the Fate of Cereal Nutrients in the Gut : Effects of Amylose Content on Glycemic Index.
- ClinicalTrials.gov ID
- NCT01437917
- Acronym / sponsor ID
- NOMAC / LOC/11-05 - NOMAC
- Conditions
- Healthy
- Keywords
- glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- Sep 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bread with 20% amylose content | Experimental | Other: 20% amylose breadBread with 20% amylose content |
| Bread with 10% amylose content | Experimental | Dietary Supplement: 10% amylose breadBread with 10% amylose content |
| carbohydrates | Experimental | Dietary Supplement: Carbohydrates50g of carbohydrates ingested with 400 ml of water |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- BMI > 25 kg/m2,
- Diabetes or any illness susceptible to alter
- Coeliac disease
- Past history of intestinal diseases.
- Treatment susceptible of modifying glycemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20% amylose bread20% amylose bread | Other | Bread with 20% amylose content |
| 10% amylose bread10% amylose bread | Dietary supplement | Bread with 10% amylose content |
| Carbohydrates50g of carbohydrates ingested with 400 ml of water | Dietary supplement | carbohydrates |
Primary outcome
Glycemic index for each bread
Time frame: 2 hours
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.
1 secondary outcome
AUC for insulinemia for the 2 hours following the ingestion of each bread.
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice BONNET, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20% amylose bread, 10% amylose bread and Carbohydrates in people with Healthy, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic index for each bread (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012.