Postprandial Glycemia After Eating a Pasta Dish Made With Resistant Starch. (ALISSEC2)

Evaluation of Postprandial Glycemia After Eating a Pasta Dish Made With Resistant Starch.

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.

Study Overview

• Status: Completed
• Conditions: Postprandial Glycemia; Resistant Starch
• Intervention / Treatment: Other: Pasta dish with resistant starch; Other: Original version of pasta dish

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Centre for Nutrition Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Subjects will consume a pasta dish with 20-22% of resistant starch	Other: Pasta dish with resistant starch; Pasta dish with 20-22% of resistant starch; Other: Original version of pasta dish; Original pasta dish, not reinforced with resistant starch
Placebo Comparator: Control group; Subjects will consume the original version of pasta dish	Other: Pasta dish with resistant starch; Pasta dish with 20-22% of resistant starch; Other: Original version of pasta dish; Original pasta dish, not reinforced with resistant starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline blood glucose	Blood glucose levels before start eating the pasta dish in each clinical investigation day will be analyzed by biochemical autoanalyzer and reported in mg/dL.	0 min in the Clinical investigation day 1 and Clinical investigation day 2 (at least 7 days after the clinical investigation day 1)
Postprandial blood glucose	Blood glucose levels after start eating the pasta dish in each clinical investigation day will be analyzed by biochemical autoanalyzer and reported in mg/dL.	30, 60, 90, 120 and 150 min after start eating the pasta dish in the Clinical investigation day 1 and Clinical investigation day 2
Glycemia Area Under the Curve	Postprandial glycemia levels after eating pasta dish in each clinical investigation day will be analyzed biochemical autoanalyzer and reported in mg/dL. Glycemia AUC will be calculated by the trapezoidal rule.	Baseline, 30, 60, 90, 120 and 150 minutes in the Clinical investigation day 1 and Clinical investigation day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulinemia Area Under the Curve	Postprandial insulin levels after eating pasta dish in each clinical investigation day will be analyzed by ELISA and reported in mU/L. Insulinemia AUC will be calculated by the trapezoidal rule.	Baseline, 30, 60, 90, 120 and 150 minutes in Clinical investigation day 1 and Clinical investigation day 2
Baseline blood insulin	Blood insulin levels before start eating the pasta dish in each clinical investigation day will be analyzed by ELISA and reported in mU/L.	0 min in the Clinical investigation day 1 and Clinical investigation day 2
Postprandial blood insulin	Blood insulin levels after start eating the pasta dish in each clinical investigation day will be analyzed by ELISA and reported in mU/L.	30, 60, 90, 120 and 150 min after start eating in the Clinical investigation day 1 and Clinical investigation day 2.
Body weight	Weight of participants will be measured by bioimpedance and reported in kg	Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
Height	Height of participants will be measured by stadiometer and reported in m.	Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
Body mass index	Body mass index will be calculated as follows: weight (kg)/ height (cm)2.	Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
Acceptance of pasta dish	Pasta dish acceptance will be analyzed by acceptance questionnaire.	Clinical Investigation Day 1 (after eat the pasta dish) and Clinical Investigation Day 2 (after eat the pasta dish)

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Investigators: Principal Investigator: Fermín I Milagro Yoldi, PhD, University of Navarra; Study Chair: Idoia Ibero-Baraibar, PhD, University of Navarra; Study Chair: Carlos J González-Navarro, PhD, University of Navarra; Study Chair: Miguel López-Yoldi, PhD, University of Navarra; Study Chair: Salomé Pérez Diez, University of Navarra; Study Chair: Blanca Martínez de Morentin, University of Navarra; Study Chair: José I Riezu-Boj, PhD, University of Navarra

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Postprandial glycemia; Resistant starch; Pasta; Postprandial insulinemia
• Other Study ID Numbers: ALISSEC 2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No