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

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.

Study Overview

• Status: Completed
• Conditions: Dietary Modification
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Parma, Italy, 43125
    • Department of Food and Drugs, University of Parma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

8

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-prandial glycemic response	Post-prandial glycemic response (iAUC)	2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-prandial response for insulin	Post-prandial response for insulin (iAUC)	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	2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Parma

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 12, 2018
• Primary Completion (ACTUAL): November 15, 2018
• Study Completion (ACTUAL): November 15, 2018

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (ACTUAL): October 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: BIO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No