Dietary Modification Clinical Trial
Official title:
Breads Made With Triticum Heritage Varieties: Effect on Post-prandial Glycemia and Insulinemia
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 |
Verified date | March 2019 |
Source | University of Parma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Food and Drugs, University of Parma | Parma |
Lead Sponsor | Collaborator |
---|---|
University of Parma |
Italy,
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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