Postprandial GlycemiaALISSEC2NCT05988580
Postprandial Glycemia After Eating a Pasta Dish Made With Resistant Starch.
A study testing Pasta dish with resistant starch and Original version of pasta dish in people with Postprandial Glycemia and Resistant Starch, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glycemia, Resistant Starch
- What is being tested?
- Pasta dish with resistant starch and Original version of pasta dish
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
For this purpose, a randomized, double blind crossover study has been designed.
Target sample size is 18 subjects.
Read the 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.
- Conditions
- Postprandial Glycemia, Resistant Starch
- Being tested
- Pasta dish with resistant starch, Original version of pasta dish
- Keywords
- Resistant starch, Postprandial glycemia, Postprandial insulinemia, Pasta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasta dish with resistant starchOther
Pasta dish with 20-22% of resistant starch
Original version of pasta dishOther
Original pasta dish, not reinforced with resistant starch
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Subjects will consume a pasta dish with 20-22% of resistant starch Receives: 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 Receives: Other: Pasta dish with resistant starch; Other: Original version of pasta dish |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Clinical Investigation Day 1 (after eat the pasta dish) and Clinical Investigation Day 2 (after eat the pasta dish)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2023
- Primary completion27 Oct 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial GlycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, double blind crossover intervention
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fermín I Milagro Yoldi, PhD, Principal investigator, University of NavarraIdoia Ibero-Baraibar, PhD, Study chair, University of NavarraCarlos J González-Navarro, PhD, Study chair, University of NavarraMiguel López-Yoldi, PhD, Study chair, University of NavarraSalomé Pérez Diez, Study chair, University of NavarraBlanca Martínez de Morentin, Study chair, University of NavarraJosé I Riezu-Boj, PhD, Study chair, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988580
- Sponsor's protocol ID
- ALISSEC 2.0
- Acronym
- ALISSEC2
- Status last verified
- Jul 2023
- First submitted
- 4 Aug 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postprandial Glycemia After Eating a Pasta Dish Made With Resistant Starch.
- ClinicalTrials.gov ID
- NCT05988580
- Acronym / sponsor ID
- ALISSEC2 / ALISSEC 2.0
- Conditions
- Postprandial Glycemia, Resistant Starch
- Keywords
- Resistant starch, Postprandial glycemia, Postprandial insulinemia, Pasta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double blind crossover intervention
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Pasta dish with resistant starch, Other: Original version of pasta dishSubjects will consume a pasta dish with 20-22% of resistant starch |
| Control group | Placebo comparator | Other: Pasta dish with resistant starch, Other: Original version of pasta dishSubjects will consume the original version of pasta dish |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasta dish with resistant starchPasta dish with 20-22% of resistant starch | Other | Control group, Experimental group |
| Original version of pasta dishOriginal pasta dish, not reinforced with resistant starch | Other | Control group, Experimental group |
Primary outcome
Baseline blood glucose
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.
Postprandial blood glucose
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.
Glycemia Area Under the Curve
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.
7 secondary outcomes
Insulinemia Area Under the Curve
Time frame: Baseline, 30, 60, 90, 120 and 150 minutes in Clinical investigation day 1 and Clinical investigation day 2
Baseline blood insulin
Time frame: 0 min in the Clinical investigation day 1 and Clinical investigation day 2
Postprandial blood insulin
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
Time frame: Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
Height
Time frame: Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
Body mass index
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
Time frame: Clinical Investigation Day 1 (after eat the pasta dish) and Clinical Investigation Day 2 (after eat the pasta dish)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fermín I Milagro Yoldi, PhD principal investigator
University of Navarra
Idoia Ibero-Baraibar, PhD study chair
University of Navarra
Carlos J González-Navarro, PhD study chair
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pasta dish with resistant starch and Original version of pasta dish in people with Postprandial Glycemia and Resistant Starch, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline blood glucose (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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.