Dietary ModificationNCT03710200
Breads Made With Triticum Heritage Varieties: Effect on Post-prandial Glycemia and Insulinemia
A study testing Bologna 00+S. cerevisiae yeast, Bologna 1+S. cerevisiae yeast and Bio2+S. cerevisiae yeast in people with Dietary Modification, run by University of Parma at 1 site in Italy.
Trial summary
Wheat is one of the most important crop for humans and it represents a source of multiple nutrients, dietary fiber and bioactive compounds, especially if consumed as wholegrain. Several studies have suggested that Triticum heritage varieties could present a healthier and better nutritional profile than modern wheats… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Bologna 00+S. cerevisiae yeast, Bologna 1+S. cerevisiae yeast and Bio2+S. cerevisiae yeast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 12 Oct 2018to 15 Nov 2018
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -generally healthy
Who cannot join
- BMI≥30kg/m2
- have any health conditions (including anemia and metabolic conditions such as hypertension, dyslipidemia, impaired glucose intolerance or diabetes)
- have celiac disease
- currently taking any prescription medication for chronic diseases (including psychiatric) dietary supplements affecting the metabolism
- Women who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Wheat is one of the most important crop for humans and it represents a source of multiple nutrients, dietary fiber and bioactive compounds, especially if consumed as wholegrain. Several studies have suggested that Triticum heritage varieties could present a healthier and better nutritional profile than modern wheats, by providing more vitamins, minerals and nutraceutical compounds. Although the effect of ancient grain consumption have been partially investigated in both animal and human studies, the potential impact of Triticum heritage varieties compared to modern ones on post-prandial glucose metabolism is still unclear. Thus, the aim of the study was to evaluate the impact on post-prandial glycaemia and insulinemia of different types of breads formulated with flours derived from mix of heritage varieties belonging to the Triticum genus selected and cultivated in specific areas of Emilia Romagna region, compared to breads made with conventional/modern wheat flours.
Read the detailed description
Cereal grain based products constitute a major part of the daily diet, and wheat is the most important crop for humans representing a source of multiple nutrients, dietary fiber and bioactive compounds, especially if consumed as wholegrain. Depending on its physical and chemicals properties, such as structure of grains, granular size of semolina, quantity and quality of fiber and phytochemicals, amylose/amylopectin ratio, wheat may vehicle protective effects on human health. After the Green Revolution, most of wheat species grown are hybrids, which derive from ancient wheat over the last 100 to 150 years. The main results of this revolution were the development of modern varieties characterized by higher yield, a reduced susceptibility to disease and insects, an increase tolerance to environmental stresses, a homogeneous maturation and a better gluten quality, compared to ancient wheat. At the same time, a decrease in genetic variability as well as a gradual depletion of the nutritional and nutraceutical properties of the wheat occurred. However, over the last years, the increase of diet-related chronic disease led to the nutritional improvement of wheat for ameliorating its health potential. Nowadays, the higher value of whole grains than refined grains is recognized, while the nutritional effects of ancient versus modern grains is still controversial. Generally, ancient species are higher in vitamins, such as folate, niacin and vitamin B6, as well as in minerals such as calcium, iron, magnesium and phosphor compared to modern species, however evidence linked to their real health in vivo effects is still lacking. Therefore, the aim of the present study is to evaluate the nutritional profile of eight breads made with ancient (Triticum heritage varieties) or modern grains on the plasma response of glucose and insulin.
- Conditions
- Dietary Modification
- Being tested
- Bologna 00+S. cerevisiae yeast, Bologna 1+S. cerevisiae yeast, Bio2+S. cerevisiae yeast, ICARDA+S. cerevisiae yeast, Bologna 1+sourdough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bologna 00+S. cerevisiae yeastOther
Bologna 00 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL of water
Bologna 1+S. cerevisiae yeastOther
Bologna 1 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
Bio2+S. cerevisiae yeastOther
Bio2 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
ICARDA+S. cerevisiae yeastOther
Icarda bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
Bologna 1+sourdoughOther
Bologna 1 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
Bio 2+sourdoughOther
109g of Bio2 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
ICARDA+sourdoughOther
Icarda bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
Grossi+sourdoughOther
Grossi bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
| Study group | Role | What they receive |
|---|---|---|
| Bologna 00+S. cerevisiae yeast | Active comparator | Bread made with Bologna flour (type 00) (modern variety)+S. cerevisiae yeast Receives: Other: Bologna 00+S. cerevisiae yeast |
| Bologna 1+S. cerevisiae yeast | Experimental | Bread made with Bologna flour (type 1) (modern variety)+S. cerevisiae yeast Receives: Other: Bologna 1+S. cerevisiae yeast |
| Bio2+S. cerevisiae yeast | Experimental | Bread made with mix Bio2 flour (type 1) (heritage mix varieties)+S. cerevisiae yeast Receives: Other: Bio2+S. cerevisiae yeast |
| ICARDA+S. cerevisiae yeast | Experimental | Bread made with Icarda mix (type 1) (heritage mix varieties)+S. cerevisiae yeast Receives: Other: ICARDA+S. cerevisiae yeast |
| Bologna 1+sourdough | Experimental | Bread made with Bologna flour (type 1) (modern variety)+sourdough Receives: Other: Bologna 1+sourdough |
| Bio2+sourdough | Experimental | Bread made with mix Bio2 flour (type 1) (heritage mix varieties)+sourdough Receives: Other: Bio 2+sourdough |
| ICARDA+sourdough | Experimental | Bread made with mix Icarda flour (type 1) (heritage mix varieties)+sourdough Receives: Other: ICARDA+sourdough |
| Grossi+sourdough | Experimental | Bread made with mix Grossi flour (type 1) (heritage mix varieties)+sourdough Receives: Other: Grossi+sourdough |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial glycemic response
Post-prandial glycemic response (iAUC)
Measured: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Secondary outcomes (2)
Post-prandial response for insulin
Post-prandial response for insulin (iAUC)
Measured: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Maximum peak for glucose and insulin
maximum value of postprandial glucose and insulin response
Measured: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start12 Oct 2018
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Scazzina Ph.D., University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710200
- Sponsor's protocol ID
- BIO2
- Status last verified
- Mar 2019
- First submitted
- 15 Oct 2018
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breads Made With Triticum Heritage Varieties: Effect on Post-prandial Glycemia and Insulinemia
- ClinicalTrials.gov ID
- NCT03710200
- Acronym / sponsor ID
- BIO2
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 18 Oct 2018 (actual)
- 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.
Wheat is one of the most important crop for humans and it represents a source of multiple nutrients, dietary fiber and bioactive compounds, especially if consumed as wholegrain. Several studies have suggested that Triticum heritage varieties could present a healthier and better nutritional profile than modern wheats, by providing more vitamins, minerals and nutraceutical compounds. Although the effect of ancient grain consumption have been partially investigated in both animal and human studies, the potential impact of Triticum heritage varieties compared to modern ones on post-prandial glucose metabolism is still unclear. Thus, the aim of the study was to evaluate the impact on post-prandial glycaemia and insulinemia of different types of breads formulated with flours derived from mix of heritage varieties belonging to the Triticum genus selected and cultivated in specific areas of Emilia Romagna region, compared to breads made with conventional/modern wheat flours.
Detailed description
Cereal grain based products constitute a major part of the daily diet, and wheat is the most important crop for humans representing a source of multiple nutrients, dietary fiber and bioactive compounds, especially if consumed as wholegrain. Depending on its physical and chemicals properties, such as structure of grains, granular size of semolina, quantity and quality of fiber and phytochemicals, amylose/amylopectin ratio, wheat may vehicle protective effects on human health. After the Green Revolution, most of wheat species grown are hybrids, which derive from ancient wheat over the last 100 to 150 years. The main results of this revolution were the development of modern varieties characterized by higher yield, a reduced susceptibility to disease and insects, an increase tolerance to environmental stresses, a homogeneous maturation and a better gluten quality, compared to ancient wheat. At the same time, a decrease in genetic variability as well as a gradual depletion of the nutritional and nutraceutical properties of the wheat occurred. However, over the last years, the increase of diet-related chronic disease led to the nutritional improvement of wheat for ameliorating its health potential. Nowadays, the higher value of whole grains than refined grains is recognized, while the nutritional effects of ancient versus modern grains is still controversial. Generally, ancient species are higher in vitamins, such as folate, niacin and vitamin B6, as well as in minerals such as calcium, iron, magnesium and phosphor compared to modern species, however evidence linked to their real health in vivo effects is still lacking. Therefore, the aim of the present study is to evaluate the nutritional profile of eight breads made with ancient (Triticum heritage varieties) or modern grains on the plasma response of glucose and insulin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Bologna 00+S. cerevisiae yeast | Active comparator | Other: Bologna 00+S. cerevisiae yeastBread made with Bologna flour (type 00) (modern variety)+S. cerevisiae yeast |
| Bologna 1+S. cerevisiae yeast | Experimental | Other: Bologna 1+S. cerevisiae yeastBread made with Bologna flour (type 1) (modern variety)+S. cerevisiae yeast |
| Bio2+S. cerevisiae yeast | Experimental | Other: Bio2+S. cerevisiae yeastBread made with mix Bio2 flour (type 1) (heritage mix varieties)+S. cerevisiae yeast |
| ICARDA+S. cerevisiae yeast | Experimental | Other: ICARDA+S. cerevisiae yeastBread made with Icarda mix (type 1) (heritage mix varieties)+S. cerevisiae yeast |
| Bologna 1+sourdough | Experimental | Other: Bologna 1+sourdoughBread made with Bologna flour (type 1) (modern variety)+sourdough |
| Bio2+sourdough | Experimental | Other: Bio 2+sourdoughBread made with mix Bio2 flour (type 1) (heritage mix varieties)+sourdough |
| ICARDA+sourdough | Experimental | Other: ICARDA+sourdoughBread made with mix Icarda flour (type 1) (heritage mix varieties)+sourdough |
| Grossi+sourdough | Experimental | Other: Grossi+sourdoughBread made with mix Grossi flour (type 1) (heritage mix varieties)+sourdough |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -generally healthy
Key exclusion criteria (5 listed)
- BMI≥30kg/m2
- have any health conditions (including anemia and metabolic conditions such as hypertension, dyslipidemia, impaired glucose intolerance or diabetes)
- have celiac disease
- currently taking any prescription medication for chronic diseases (including psychiatric) dietary supplements affecting the metabolism
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| Bologna 00+S. cerevisiae yeastBologna 00 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL of water | Other | Bologna 00+S. cerevisiae yeast |
| Bologna 1+S. cerevisiae yeastBologna 1 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water | Other | Bologna 1+S. cerevisiae yeast |
| Bio2+S. cerevisiae yeastBio2 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water | Other | Bio2+S. cerevisiae yeast |
| ICARDA+S. cerevisiae yeastIcarda bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water | Other | ICARDA+S. cerevisiae yeast |
| Bologna 1+sourdoughBologna 1 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water | Other | Bologna 1+sourdough |
| Bio 2+sourdough109g of Bio2 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water | Other | Bio2+sourdough |
| ICARDA+sourdoughIcarda bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water | Other | ICARDA+sourdough |
| Grossi+sourdoughGrossi bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water | Other | Grossi+sourdough |
Primary outcome
Post-prandial glycemic response
Time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Post-prandial glycemic response (iAUC)
2 secondary outcomes
Post-prandial response for insulin
Time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Maximum peak for glucose and insulin
Time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
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 20 Mar 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bologna 00+S. cerevisiae yeast, Bologna 1+S. cerevisiae yeast and Bio2+S. cerevisiae yeast in people with Dietary Modification, run by University of Parma at 1 site in Italy.
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 1 inclusion and 5 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 20 Mar 2019. 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 Italy. 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?
Post-prandial glycemic response (time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)). 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 20 Mar 2019.