Clinical trial NCT03710200: Breads Made With Triticum Heritage Varieties: Effect on Post-prandial Glycemia and Insulinemia
Official title: Breads Made With Triticum Heritage Varieties: Effect on Post-prandial Glycemia and Insulinemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Post-prandial glycemic response
timeFrame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Secondary outcomes:
measure: Post-prandial response for insulin
timeFrame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
measure: Maximum peak for glucose and insulin
timeFrame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Other outcomes:
measure: Satiety using a 100cm visual analog scale [ Time Frame: 2 hours ]
timeFrame: 2 hours
measure: Gastrointestinal Symptoms using a questionnaire [ Time Frame: 2 hours ]
timeFrame: 2 hours
Locations:
city: Parma
country: Italy
facility: Department of Food and Drugs, University of Parma
Study officials:
References: