Centre for Nutrition Research
Pamplona, Navarre, 31008, Spain
NCT Number: NCT05988580
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Pamplona, Navarre, 31008, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pasta dish with 20-22% of resistant starch
Original pasta dish, not reinforced with resistant starch
Time frame: 0 min in the Clinical investigation day 1 and Clinical investigation day 2 (at least 7 days after the clinical investigation day 1)
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.
Time frame: 30, 60, 90, 120 and 150 min after start eating the pasta dish in the Clinical investigation day 1 and Clinical investigation day 2
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.
Time frame: Baseline, 30, 60, 90, 120 and 150 minutes in the Clinical investigation day 1 and Clinical investigation day 2
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.
Time frame: Baseline, 30, 60, 90, 120 and 150 minutes in Clinical investigation day 1 and Clinical investigation day 2
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.
Time frame: 0 min in the Clinical investigation day 1 and Clinical investigation day 2
Blood insulin levels before start eating the pasta dish in each clinical investigation day will be analyzed by ELISA and reported in mU/L.
Time frame: 30, 60, 90, 120 and 150 min after start eating in the Clinical investigation day 1 and Clinical investigation day 2.
Blood insulin levels after start eating the pasta dish in each clinical investigation day will be analyzed by ELISA and reported in mU/L.
Time frame: Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
Weight of participants will be measured by bioimpedance and reported in kg
Time frame: Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
Height of participants will be measured by stadiometer and reported in m.
Time frame: Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
Body mass index will be calculated as follows: weight (kg)/ height (cm)2.
Time frame: Clinical Investigation Day 1 (after eat the pasta dish) and Clinical Investigation Day 2 (after eat the pasta dish)
Pasta dish acceptance will be analyzed by acceptance questionnaire.
Clinica Universidad de Navarra, Universidad de Navarra
Other
Evaluation of Postprandial Glycemia After Eating a Pasta Dish Made With Resistant Starch.
Acronym: ALISSEC2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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