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: * 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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
18
Pasta dish with 20-22% of resistant starch
Original pasta dish, not reinforced with resistant starch
Centre for Nutrition Research
Pamplona, Navarre, Spain
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.
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)
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.
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
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.
Time frame: Baseline, 30, 60, 90, 120 and 150 minutes in the Clinical investigation day 1 and Clinical investigation day 2
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Clinical Investigation Day 1 (after eat the pasta dish) and Clinical Investigation Day 2 (after eat the pasta dish)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.