Status:
COMPLETED
Postprandial Glycemia After Eating a Pasta Dish Made With Resistant Starch.
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Postprandial Glycemia
Resistant Starch
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Resistant starch partially resists hydrolyzation by digestive enzymes in humans. Consequently, it is not absorbed in the small intestine and goes directly to the large intestine, where it is fermented...
Detailed Description
The arms of the study are two: * Experimental group (pasta dish made with resistant starch). * Control group (original pasta dish). Volunteers who wish to participate in the study will be interviewe...
Eligibility Criteria
Inclusion
- Age: 18-65 years.
- Body mass index: 18.5-29.9 kg/m2
- Volunteers who like and feel good with the ingredients of the dish.
- Good physical and psychological state.
- Volunteers undergoing pharmacological treatment will be maintained if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function or glucose metabolism.
- Subjects must be able to understand and be willing to sign the informed consent, and must comply with all the procedures and requirements of the study.
- No weight variations considered relevant (+/- 3kg) in the last 3 months.
Exclusion
- Subjects with relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux, etc.
- Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
- Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).
- Women who are breastfeeding or pregnant.
- Subjects with liver disease.
- Subjects with some type of cancer or undergoing treatment for it, or who have not had a period of at least 5 years since its eradication.
- Subjects with allergies to any component of the product under study or any other food that interferes and makes it difficult to monitor the study.
- Subjects who present some type of cognitive and/or psychic impairment.
- Subjects in whom poor collaboration is expected or who, in the opinion of the investigator, have difficulties in following the study procedures.
- Subjects who work the night shift.
- Subjects who follow some type of supplementation that interferes with the study.
- Subjects who are immersed in some treatment for weight loss.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05988580
Start Date
September 1 2023
End Date
November 15 2023
Last Update
January 12 2024
Active Locations (1)
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1
Centre for Nutrition Research
Pamplona, Navarre, Spain, 31008