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

NCT05988580 | Completed

• 1 other identifier: ALISSEC 2.0
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Glycemia; Resistant Starch

Keywords

Resistant starch; Postprandial glycemia; Postprandial insulinemia; Pasta

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Insulinemia Area Under the Curve

  Baseline, 30, 60, 90, 120 and 150 minutes in Clinical investigation day 1 and Clinical investigation day 2

• Baseline blood insulin

  0 min in the Clinical investigation day 1 and Clinical investigation day 2

• Postprandial blood insulin

  30, 60, 90, 120 and 150 min after start eating in the Clinical investigation day 1 and Clinical investigation day 2.

• Body weight

  Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)

• Height

  Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)

Study Arms (2)

Experimental group

EXPERIMENTAL

Subjects will consume a pasta dish with 20-22% of resistant starch

Other: Pasta dish with resistant starch; Other: Original version of pasta dish

Control group

PLACEBO COMPARATOR

Subjects will consume the original version of pasta dish

Other: Pasta dish with resistant starch; Other: Original version of pasta dish

Interventions

Pasta dish with resistant starch OTHER

Pasta dish with 20-22% of resistant starch

Control group; Experimental group

Original version of pasta dish OTHER

Original pasta dish, not reinforced with resistant starch

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Balanced in men and women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Centre for Nutrition Research

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Interventions

Resistant Starch

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Fermín I Milagro Yoldi, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The products (experimental and placebo), will be produced by an external producer, who will retain the codes. None of the researchers involved in the study development or analyses will know the association until the end of the study.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, double blind crossover intervention

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2023
• Primary Completion: October 27, 2023
• Study Completion: November 15, 2023
• Last Updated: January 12, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)