Breads Made With Triticum Heritage Varieties: Effect on Post-prandial Glycemia and Insulinemia

• ClinicalTrials.gov Identifier: NCT03710200
• Recruitment Status: Completed
• First Posted: October 18, 2018
• Last Update Posted: March 20, 2019
• Sponsor: University of Parma
• Information provided by (Responsible Party): Francesca Scazzina Ph.D., University of Parma

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dietary Modification	Other: Bologna 00+S. cerevisiae yeast; Other: Bologna 1+S. cerevisiae yeast; Other: Bio2+S. cerevisiae yeast; Other: ICARDA+S. cerevisiae yeast; Other: Bologna 1+sourdough; Other: Bio 2+sourdough; Other: ICARDA+sourdough; Other: Grossi+sourdough	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Breads Made With Triticum Heritage Varieties: Effect on Post-prandial Glycemia and Insulinemia
• Actual Study Start Date: October 12, 2018
• Actual Primary Completion Date: November 15, 2018
• Actual Study Completion Date: November 15, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Bologna 00+S. cerevisiae yeast; Bread made with Bologna flour (type 00) (modern variety)+S. cerevisiae yeast	Other: Bologna 00+S. cerevisiae yeast; Bologna 00 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL of water
Experimental: Bologna 1+S. cerevisiae yeast; Bread made with Bologna flour (type 1) (modern variety)+S. cerevisiae yeast	Other: Bologna 1+S. cerevisiae yeast; Bologna 1 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
Experimental: Bio2+S. cerevisiae yeast; Bread made with mix Bio2 flour (type 1) (heritage mix varieties)+S. cerevisiae yeast	Other: Bio2+S. cerevisiae yeast; Bio2 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
Experimental: ICARDA+S. cerevisiae yeast; Bread made with Icarda mix (type 1) (heritage mix varieties)+S. cerevisiae yeast	Other: ICARDA+S. cerevisiae yeast; Icarda bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
Experimental: Bologna 1+sourdough; Bread made with Bologna flour (type 1) (modern variety)+sourdough	Other: Bologna 1+sourdough; Bologna 1 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
Experimental: Bio2+sourdough; Bread made with mix Bio2 flour (type 1) (heritage mix varieties)+sourdough	Other: Bio 2+sourdough; 109g of Bio2 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
Experimental: ICARDA+sourdough; Bread made with mix Icarda flour (type 1) (heritage mix varieties)+sourdough	Other: ICARDA+sourdough; Icarda bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
Experimental: Grossi+sourdough; Bread made with mix Grossi flour (type 1) (heritage mix varieties)+sourdough	Other: Grossi+sourdough; Grossi bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water

Outcome Measures

Primary Outcome Measures :

1. Post-prandial glycemic response [ Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes) ]
   Post-prandial glycemic response (iAUC)

Secondary Outcome Measures :

1. Post-prandial response for insulin [ Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes) ]
   Post-prandial response for insulin (iAUC)
2. Maximum peak for glucose and insulin [ Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes) ]
   maximum value of postprandial glucose and insulin response

Other Outcome Measures:

1. Satiety using a 100cm visual analog scale [ Time Frame: 2 hours ] [ Time Frame: 2 hours ]
   differences in subject-rated satiety using a 100cm visual analog scale
2. Gastrointestinal Symptoms using a questionnaire [ Time Frame: 2 hours ] [ Time Frame: 2 hours ]
   differences in subject-rated gastrointestinal symptom questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

-generally healthy

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Italy

Department of Food and Drugs, University of Parma

Parma, Italy, 43125

Sponsors and Collaborators

University of Parma

More Information

• Responsible Party: Francesca Scazzina Ph.D., Assistant Professor, University of Parma
• ClinicalTrials.gov Identifier: NCT03710200
• Other Study ID Numbers: BIO2
• First Posted: October 18, 2018
• Last Update Posted: March 20, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No