Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The arms of the study are two:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Subjects will consume a pasta dish with 20-22% of resistant starch |
|
| Control group | Placebo Comparator | Subjects will consume the original version of pasta dish |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasta dish with resistant starch | Other | Pasta dish with 20-22% of resistant starch |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Balanced in men and women
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| FermÃn 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 MartÃnez de Morentin | University of Navarra | Study Chair |
| José I Riezu-Boj, PhD | University of Navarra | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Nutrition Research | Pamplona | Navarre | 31008 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000084922 | Resistant Starch |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
Not provided
Not provided
Randomised, double blind crossover intervention
Not provided
Not provided
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.
| Original version of pasta dish | Other | Original pasta dish, not reinforced with resistant starch |
|
| 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) |
| Macromolecular Substances |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |