Breads Made With Triticum Heritage Varieties: Effect on Post-prandial Glycemia and Insulinemia
1 other identifier
interventional
13
1 country
1
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2018
CompletedFirst Submitted
Initial submission to the registry
October 15, 2018
CompletedFirst Posted
Study publicly available on registry
October 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2018
CompletedMarch 20, 2019
March 1, 2019
1 month
October 15, 2018
March 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Post-prandial glycemic response
Post-prandial glycemic response (iAUC)
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Secondary Outcomes (2)
Post-prandial response for insulin
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Maximum peak for glucose and insulin
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Other Outcomes (2)
Satiety using a 100cm visual analog scale [ Time Frame: 2 hours ]
2 hours
Gastrointestinal Symptoms using a questionnaire [ Time Frame: 2 hours ]
2 hours
Study Arms (8)
Bologna 00+S. cerevisiae yeast
ACTIVE COMPARATORBread made with Bologna flour (type 00) (modern variety)+S. cerevisiae yeast
Bologna 1+S. cerevisiae yeast
EXPERIMENTALBread made with Bologna flour (type 1) (modern variety)+S. cerevisiae yeast
Bio2+S. cerevisiae yeast
EXPERIMENTALBread made with mix Bio2 flour (type 1) (heritage mix varieties)+S. cerevisiae yeast
ICARDA+S. cerevisiae yeast
EXPERIMENTALBread made with Icarda mix (type 1) (heritage mix varieties)+S. cerevisiae yeast
Bologna 1+sourdough
EXPERIMENTALBread made with Bologna flour (type 1) (modern variety)+sourdough
Bio2+sourdough
EXPERIMENTALBread made with mix Bio2 flour (type 1) (heritage mix varieties)+sourdough
ICARDA+sourdough
EXPERIMENTALBread made with mix Icarda flour (type 1) (heritage mix varieties)+sourdough
Grossi+sourdough
EXPERIMENTALBread made with mix Grossi flour (type 1) (heritage mix varieties)+sourdough
Interventions
Bologna 00 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL of water
Bologna 1 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
Bio2 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
Icarda bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
Bologna 1 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
109g of Bio2 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
Icarda bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
Grossi bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
Eligibility Criteria
You may qualify if:
- generally healthy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Food and Drugs, University of Parma
Parma, 43125, Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 15, 2018
First Posted
October 18, 2018
Study Start
October 12, 2018
Primary Completion
November 15, 2018
Study Completion
November 15, 2018
Last Updated
March 20, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share