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Completed

NCT Number: NCT03710200

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Drugs, University of Parma

Parma, 43125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bologna 00+S. cerevisiae yeast

Other

Bologna 00 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL of water

Bologna 1+S. cerevisiae yeast

Other

Bologna 1 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water

Bio2+S. cerevisiae yeast

Other

Bio2 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water

ICARDA+S. cerevisiae yeast

Other

Icarda bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water

Bologna 1+sourdough

Other

Bologna 1 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water

Bio 2+sourdough

Other

109g of Bio2 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water

ICARDA+sourdough

Other

Icarda bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water

Grossi+sourdough

Other

Grossi bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2018
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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