Clinical trial NCT05988580: Postprandial Glycemia After Eating a Pasta Dish Made With Resistant Starch.
Official title: Evaluation of Postprandial Glycemia After Eating a Pasta Dish Made With Resistant Starch.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Glycemia
Resistant Starch
Keywords: Resistant starch
Postprandial glycemia
Postprandial insulinemia
Pasta
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, double blind crossover intervention
Primary purpose: PREVENTION

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 by the intestinal microbiota, acting as a prebiotic and stimulating the growth of beneficial bacteria in the colon. In addition, the effect of resistant starch on postprandial glucose metabolism is studying. Thus, the present research on healthy subjects has been proposed.

The main objective is to assess the effect on postprandial glycemia of eating a pasta dish made with resistant starch versus its original version.

For this purpose, a randomized, double blind crossover study has been designed.

Target sample size is 18 subjects.

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 interviewed by phone to verify that they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts. Volunteers who agree to participate in the study will sign the informed consent and will be randomly assigned to one of the two arms of the study.

The two visits (clinical investigation days) of the study will take place with the volunteers in a fasting state of 4 hours and separated by at least 1 week washout period. The day before the visit, volunteers won't be able to drink alcohol, drink and eat excessively, and/or sleep few hours. Both visits will consist of eating a pasta dish in a maximum of 15 minutes. Blood samples will be taken before eating and during the 2.5 hours after (30, 60, 90, 120 and 150 minutes), in order to analyze the evolution of blood glucose and insulin levels.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Baseline blood glucose
timeFrame: 0 min in the Clinical investigation day 1 and Clinical investigation day 2 (at least 7 days after the clinical investigation day 1)
measure: Postprandial blood glucose
timeFrame: 30, 60, 90, 120 and 150 min after start eating the pasta dish in the Clinical investigation day 1 and Clinical investigation day 2
measure: Glycemia Area Under the Curve
timeFrame: Baseline, 30, 60, 90, 120 and 150 minutes in the Clinical investigation day 1 and Clinical investigation day 2
Secondary outcomes:
measure: Insulinemia Area Under the Curve
timeFrame: Baseline, 30, 60, 90, 120 and 150 minutes in Clinical investigation day 1 and Clinical investigation day 2
measure: Baseline blood insulin
timeFrame: 0 min in the Clinical investigation day 1 and Clinical investigation day 2
measure: Postprandial blood insulin
timeFrame: 30, 60, 90, 120 and 150 min after start eating in the Clinical investigation day 1 and Clinical investigation day 2.
measure: Body weight
timeFrame: Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
measure: Height
timeFrame: Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
measure: Body mass index
timeFrame: Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
measure: Acceptance of pasta dish
timeFrame: Clinical Investigation Day 1 (after eat the pasta dish) and Clinical Investigation Day 2 (after eat the pasta dish)
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Centre for Nutrition Research
state: Navarre
Study officials:
affiliation: University of Navarra
name: Fermín I Milagro Yoldi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Navarra
name: Idoia Ibero-Baraibar, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Carlos J González-Navarro, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Miguel López-Yoldi, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Salomé Pérez Diez
role: STUDY_CHAIR
affiliation: University of Navarra
name: Blanca Martínez de Morentin
role: STUDY_CHAIR
affiliation: University of Navarra
name: José I Riezu-Boj, PhD
role: STUDY_CHAIR
References: