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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03710200
Other study ID # BIO2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 12, 2018
Est. completion date November 15, 2018

Study information

Verified date March 2019
Source University of Parma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date November 15, 2018
Est. primary completion date November 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Bologna 00+S. cerevisiae yeast
Bologna 00 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL of water
Bologna 1+S. cerevisiae yeast
Bologna 1 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
Bio2+S. cerevisiae yeast
Bio2 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
ICARDA+S. cerevisiae yeast
Icarda bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
Bologna 1+sourdough
Bologna 1 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
Bio 2+sourdough
109g of Bio2 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
ICARDA+sourdough
Icarda bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
Grossi+sourdough
Grossi bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water

Locations

Country Name City State
Italy Department of Food and Drugs, University of Parma Parma

Sponsors (1)

Lead Sponsor Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Other Satiety using a 100cm visual analog scale [ Time Frame: 2 hours ] differences in subject-rated satiety using a 100cm visual analog scale 2 hours
Other Gastrointestinal Symptoms using a questionnaire [ Time Frame: 2 hours ] differences in subject-rated gastrointestinal symptom questionnaire 2 hours
Primary Post-prandial glycemic response Post-prandial glycemic response (iAUC) 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Secondary Post-prandial response for insulin Post-prandial response for insulin (iAUC) 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Secondary 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)
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