AgingNCT05955131
Bread Supplemented With Chilean Beans to Decrease Postprandial Glycoxidative Responses: A Pilot Intervention
A study testing Nutritional acute postprandial intervention: bread suppelmented with Chilean beans in people with Aging, run by University of Talca at 1 site in Chile.
Trial summary
The goal of this trial is to assess in healthy subjects between 60 and 70 years the effect of glycemic and glycoxidative postprandial responses and platelet aggregation after intake of bread supplemented with Chilean beans flour when compared with a non supplemented control. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Nutritional acute postprandial intervention: bread suppelmented with Chilean beans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChile
- Study dates
- 5 May 2023to 30 Apr 2024
- 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 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons between 60-70 years old.
- Persons autonomous.
- Persons who are willing to participate in this study and who have agreed and signed the informed consent.
Who cannot join
- Clinical diagnosis of diabetes
- Persons with levels of glycosylated hemoglobin (HbA1c) lhigher than 6.5
- Clinical diagnosis and uncontrolled chronic diseases.
- Anemia, dtermined by ferritin levels less than 15 µg/ L.
- Oropharyngeal disorders (self-reported).
- Persons with gastric bypass surgery.
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- Celiac disease (self-reported).
- Coagulation disorders (self-reported).
- Use of medications that modify the glycemic response or lipid profile (acarbose, thiazolinediones, metformin, insulin, orlistat, among others).
- Clinical diagnosis of Alzheimer's disease or sinile dementia.
- People with pacemakers or metal subcutaneous implants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Formulación de Productos de panificación Suplementados Con Harina de Porotos Nativos Chilenos Para Disminuir Respuestas glicémicas Postprandiales y agregación Plaquetaria en Personas Mayores: Un Estudio Piloto
The goal of this trial is to assess in healthy subjects between 60 and 70 years the effect of glycemic and glycoxidative postprandial responses and platelet aggregation after intake of bread supplemented with Chilean beans flour when compared with a non supplemented control. The main questions to answer are:
- It is possible to decrease postprandial glycemic and glycoxidative responses by means of the intake of bread supplemented with Chilean beans flour when compared to the intake of a control bread non supplemented in healthy elderly persons?
- How is affected the platelet aggregation process during postprandial state after intake of bread supplemented with Chilean beans flour, when compared to the intake of a control bread non supplemented in healthy elderly persons?
Read more
Participants will:
- Be characterized by means of: 1) evaluation of body composition, using anthropometric techniques, bioimpedance and 2) biochemical analyses: biochemical profile, lipid profile, serum ferritin, fasting glycemia, HbA1c and insulin.
- Arrive at fast to the laboratory and eat randomly control bread, 30% Chilean beans supplemented bread or glucose. Venous blood samples will be taken from the cubital fossa of the dominant arm at: 0, 30, 60 and 120 min postprandial, only after intake of bread control and supplemented bread. In addition, capillary blood will be taken at 0, 15, 30, 60, 90 and 120 min postprandial after intake of glucose, bread control or supplemented bread.
Read the detailed description
Screening and initial characterization:
Initial screening: General health status will be consulted, and glycemia will be measured at any time, using a hemoglucotest. If eligible (glycemia at any time less than 140 mg/dL), the subjects will be invited to participate in the initial characterization and postprandial study.
Initial characterization:
A medical and nutritional evaluation will be carried out. A medical doctor will ask the volunteers for general information about their state of health and medication consumption.
The nutritional evaluation (weight, height, waist circumference and body composition) will be carried out in the Nutritional Status Evaluation Laboratory of the School of Nutrition and Dietetics of the University of Talca.
For the bioimpedance studies, volunteers will be asked prior to the assessment to:
- Do not drink alcohol 48 hours before the analysis.
- Having urinated 30 minutes before the analysis.
- Attend the laboratory on fasting, special care must be taken not to drink coffee 4 hours before the measurement.
- When the volunteers arrive at the laboratory, they will be asked to sit on a platform barefoot and without jewelry or metals, with the least amount of clothing possible (light clothing, light overalls, and a T-shirt to have a more exact weight, they will be asked to avoid wearing jeans that day).
- For the measurement of the waist circumference, the volunteers will be asked to lift their shirt or blouse, until their ribs or equivalent height can be seen. These measurements will be performed by a Nutritionist in an office to protect the privacy of the volunteers.
- Clinical laboratory blood samples. Participants will be informed by telephone of the day on which blood samples will be taken, for which they will be asked to eat their last meal at 11:00 p.m. the night before the blood test. The van will pick them up at their home, 11-12 people in total. The blood sample will be taken at the Fleming Clinic.
- Once the results are known, at least one week in advance, we will contact the volunteers by phone to make an appointment with the doctor and eat the first of four meals.
Food intake and blood sampling.
On the day of meal intake, volunteers will be asked to have their last meal at 11:00 p.m. the day before it will be presented in the laboratory. A van will pick up the volunteers between 6:30-8:00 a.m. They will be transferred to the Fleming Clinic along with 11-12 other people to the laboratory. Once in the laboratory, two types of blood samples will be taken:
- Capillary blood: pricking a fingertip with a sterile lancet. A nutritionist will clean the finger of the volunteers with alcohol and later they will feel a slight prick, lasting less than a second. Capillary glycemia will be measured with that blood. This procedure will be carried out at times 0, 15, 30, 45, 60, 90 and 120 min after eating bread or glucose.
- Venous blood: upon arrival at the laboratory (fasting) a Nurse will insert a conventional venous line in the arm. A 5 mL sample (equivalent to a teaspoon) of blood will be drawn at the following times: 0, 30, 60, and 120 min. Per day each volunteer will donate aprox. 20mL of blood, equivalent to approximately two tablespoons.
After arriving at the laboratory and taking the samples fasting (time 0), the volunteers will randomly receive one of the 2 samples of bread or glucose. If they receive glucose, only capillary blood samples will be taken.
If they receive a sample of bread, the volunteer must eat approximately 100 g (amount containing 50g of carbohydrates), (equivalent to 1 common bread) of the bread manufactured by us, along with 250 mL of water. Food intake time will be timed, and the volunteers should eat slowly but steadily. The intake time from the first bite to the last cannot exceed 10 minutes.
- Conditions
- Aging
- Being tested
- Nutritional acute postprandial intervention: Control bread, Nutritional acute postprandial intervention: bread suppelmented with Chilean beans, Nutritional acute postprandial intervention: Control glucose
- Keywords
- Oxidative stress, Glycoxidation, Advanced glycation end products, Aging, Bread, Antioxidants, Fiber, Platelet aggregation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional acute postprandial intervention: Control breadOther
Volunteers will arrive at fasting and blood samples (aprox. 5mL) will be obtained before (0 min) and after the intake (10 min of intake) an amount of control bread containing 50g of carbohydrates, venous blood samples for determination of insulin, methyglyoxal, 3-deoxyglucosone and platelet aggregation will be collected at 30, 60, 90 and 120 mn postprandial. In addition, capillary slood will be obtained at 0, 15, 30, 60, 90 and 120 postprandial for glycemia determination
Nutritional acute postprandial intervention: bread suppelmented with Chilean beansOther
Volunteers will arrive at fasting and blood samples (aprox. 5mL) will be obtained before (0 min) and after the intake (10 min of intake) an amount of supplemented bread containing 50g of carbohydrates, venous blood samples for determination of insulin, methyglyoxal, 3-deoxyglucosone and platelet aggregation will be collected at 30, 60, 90 and 120 mn postprandial. In addition, capillary slood will be obtained at 0, 15, 30, 60, 90 and 120 postprandial for glycemia determination.
Nutritional acute postprandial intervention: Control glucoseOther
Volunteers will arrive at fasting and capillary blood samples will be obtained before (0 min) and after the intake an amount of control glucose containing 50g of this monosscharide (10 min of intake), capillary slood will be also obtained at 15, 30, 60, 90 and 120 postprandial for glycemia determination.
| Study group | Role | What they receive |
|---|---|---|
| Control Bread | Other | Subjects will eat control bread, in an amount containing 50g of carbohydrates Receives: Other: Nutritional acute postprandial intervention: Control bread |
| Bread Supplemented with Chilean Beans | Experimental | Subjects will eat bread supplemented with Chilean native beans at 30% w/w, in an amount containing 50g of carbohydrates Receives: Other: Nutritional acute postprandial intervention: bread suppelmented with Chilean beans |
| Glucose control | Other | Subjects will drink glucose, in an amount containing 50g of carbohydrates Receives: Other: Nutritional acute postprandial intervention: Control glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the postprandial levels of methylglyoxal in plasma
Determiantion of the change in the levels of methylglyoxal in plasma by means of pre-column derivatization and posterior separation, detection and quantification by means of high performance liquid chromatography and detection by fluorescence
Measured: 0, 30, 60 and 120 min postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start5 May 2023
- Primary completion30 May 2023
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- This study involves an acute nutritional intervention with crossover design, in which each volunteer will eat one out of tree meals (control bread, supplemented bread or glucose), randomly, once by week. Blood samples will be taken at 0min and 30, 60 and 120 min postprandial. The volunteers will complete their participation after the intake of the three meals, hence, their participation in the study will finish after 3 weeks.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Talca
- Sponsor type
- University, hospital or other
- Collaborators
- Interuniversity Center for Healthy Aging, Centro de Estudios en Alimentos Procesados, Clínica Fleming de Talca
- Responsible party
- Principal investigator, Felipe Ávila Concha, University of Talca
- Investigators
- Felipe Ávila, PhD, Principal investigator, School of Nutrition and Dietetics, Health Sciences Faculty, University of Talca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955131
- Sponsor's protocol ID
- CIES 002
- Status last verified
- Jul 2023
- First submitted
- 27 Jun 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This was not authorized by the Institutional Ethics Comitee
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formulación de Productos de panificación Suplementados Con Harina de Porotos Nativos Chilenos Para Disminuir Respuestas glicémicas Postprandiales y agregación Plaquetaria en Personas Mayores: Un Estudio Piloto
- ClinicalTrials.gov ID
- NCT05955131
- Acronym / sponsor ID
- CIES 002
- Conditions
- Aging
- Keywords
- Oxidative stress, Glycoxidation, Advanced glycation end products, Aging, Bread, Antioxidants, Fiber, Platelet aggregation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of TalcaUniversity, hospital or other
- Collaborators
- Interuniversity Center for Healthy Aging, Centro de Estudios en Alimentos Procesados, Clínica Fleming de Talca
- Study start
- 5 May 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 21 Jul 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.
The goal of this trial is to assess in healthy subjects between 60 and 70 years the effect of glycemic and glycoxidative postprandial responses and platelet aggregation after intake of bread supplemented with Chilean beans flour when compared with a non supplemented control. The main questions to answer are:
- It is possible to decrease postprandial glycemic and glycoxidative responses by means of the intake of bread supplemented with Chilean beans flour when compared to the intake of a control bread non supplemented in healthy elderly persons?
- How is affected the platelet aggregation process during postprandial state after intake of bread supplemented with Chilean beans flour, when compared to the intake of a control bread non supplemented in healthy elderly persons?
Participants will:
- Be characterized by means of: 1) evaluation of body composition, using anthropometric techniques, bioimpedance and 2) biochemical analyses: biochemical profile, lipid profile, serum ferritin, fasting glycemia, HbA1c and insulin.
- Arrive at fast to the laboratory and eat randomly control bread, 30% Chilean beans supplemented bread or glucose. Venous blood samples will be taken from the cubital fossa of the dominant arm at: 0, 30, 60 and 120 min postprandial, only after intake of bread control and supplemented bread. In addition, capillary blood will be taken at 0, 15, 30, 60, 90 and 120 min postprandial after intake of glucose, bread control or supplemented bread.
Detailed description
Screening and initial characterization:
Initial screening: General health status will be consulted, and glycemia will be measured at any time, using a hemoglucotest. If eligible (glycemia at any time less than 140 mg/dL), the subjects will be invited to participate in the initial characterization and postprandial study.
Initial characterization:
A medical and nutritional evaluation will be carried out. A medical doctor will ask the volunteers for general information about their state of health and medication consumption.
The nutritional evaluation (weight, height, waist circumference and body composition) will be carried out in the Nutritional Status Evaluation Laboratory of the School of Nutrition and Dietetics of the University of Talca.
For the bioimpedance studies, volunteers will be asked prior to the assessment to:
- Do not drink alcohol 48 hours before the analysis.
- Having urinated 30 minutes before the analysis.
- Attend the laboratory on fasting, special care must be taken not to drink coffee 4 hours before the measurement.
- When the volunteers arrive at the laboratory, they will be asked to sit on a platform barefoot and without jewelry or metals, with the least amount of clothing possible (light clothing, light overalls, and a T-shirt to have a more exact weight, they will be asked to avoid wearing jeans that day).
- For the measurement of the waist circumference, the volunteers will be asked to lift their shirt or blouse, until their ribs or equivalent height can be seen. These measurements will be performed by a Nutritionist in an office to protect the privacy of the volunteers.
- Clinical laboratory blood samples. Participants will be informed by telephone of the day on which blood samples will be taken, for which they will be asked to eat their last meal at 11:00 p.m. the night before the blood test. The van will pick them up at their home, 11-12 people in total. The blood sample will be taken at the Fleming Clinic.
- Once the results are known, at least one week in advance, we will contact the volunteers by phone to make an appointment with the doctor and eat the first of four meals.
Food intake and blood sampling.
On the day of meal intake, volunteers will be asked to have their last meal at 11:00 p.m. the day before it will be presented in the laboratory. A van will pick up the volunteers between 6:30-8:00 a.m. They will be transferred to the Fleming Clinic along with 11-12 other people to the laboratory. Once in the laboratory, two types of blood samples will be taken:
- Capillary blood: pricking a fingertip with a sterile lancet. A nutritionist will clean the finger of the volunteers with alcohol and later they will feel a slight prick, lasting less than a second. Capillary glycemia will be measured with that blood. This procedure will be carried out at times 0, 15, 30, 45, 60, 90 and 120 min after eating bread or glucose.
- Venous blood: upon arrival at the laboratory (fasting) a Nurse will insert a conventional venous line in the arm. A 5 mL sample (equivalent to a teaspoon) of blood will be drawn at the following times: 0, 30, 60, and 120 min. Per day each volunteer will donate aprox. 20mL of blood, equivalent to approximately two tablespoons.
After arriving at the laboratory and taking the samples fasting (time 0), the volunteers will randomly receive one of the 2 samples of bread or glucose. If they receive glucose, only capillary blood samples will be taken.
If they receive a sample of bread, the volunteer must eat approximately 100 g (amount containing 50g of carbohydrates), (equivalent to 1 common bread) of the bread manufactured by us, along with 250 mL of water. Food intake time will be timed, and the volunteers should eat slowly but steadily. The intake time from the first bite to the last cannot exceed 10 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- This study involves an acute nutritional intervention with crossover design, in which each volunteer will eat one out of tree meals (control bread, supplemented bread or glucose), randomly, once by week. Blood samples will be taken at 0min and 30, 60 and 120 min postprandial. The volunteers will complete their participation after the intake of the three meals, hence, their participation in the study will finish after 3 weeks.
| Arm | Type | Receives |
|---|---|---|
| Control Bread | Other | Other: Nutritional acute postprandial intervention: Control breadSubjects will eat control bread, in an amount containing 50g of carbohydrates |
| Bread Supplemented with Chilean Beans | Experimental | Other: Nutritional acute postprandial intervention: bread suppelmented with Chilean beansSubjects will eat bread supplemented with Chilean native beans at 30% w/w, in an amount containing 50g of carbohydrates |
| Glucose control | Other | Other: Nutritional acute postprandial intervention: Control glucoseSubjects will drink glucose, in an amount containing 50g of carbohydrates |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persons between 60-70 years old.
- Persons autonomous.
- Persons who are willing to participate in this study and who have agreed and signed the informed consent.
Key exclusion criteria (11 listed)
- Clinical diagnosis of diabetes
- Persons with levels of glycosylated hemoglobin (HbA1c) lhigher than 6.5
- Clinical diagnosis and uncontrolled chronic diseases.
- Anemia, dtermined by ferritin levels less than 15 µg/ L.
- Oropharyngeal disorders (self-reported).
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 |
|---|---|---|
| Nutritional acute postprandial intervention: Control breadVolunteers will arrive at fasting and blood samples (aprox. 5mL) will be obtained before (0 min) and after the intake (10 min of intake) an amount of control bread containing 50g of carbohydrates, venous blood samples for determination of insulin, methyglyoxal, 3-deoxyglucosone and platelet aggregation will be collected at 30, 60, 90 and 120 mn postprandial. In addition, capillary slood will be obtained at 0, 15, 30, 60, 90 and 120 postprandial for glycemia determination | Other | Control Bread |
| Nutritional acute postprandial intervention: bread suppelmented with Chilean beansVolunteers will arrive at fasting and blood samples (aprox. 5mL) will be obtained before (0 min) and after the intake (10 min of intake) an amount of supplemented bread containing 50g of carbohydrates, venous blood samples for determination of insulin, methyglyoxal, 3-deoxyglucosone and platelet aggregation will be collected at 30, 60, 90 and 120 mn postprandial. In addition, capillary slood will be obtained at 0, 15, 30, 60, 90 and 120 postprandial for glycemia determination. | Other | Bread Supplemented with Chilean Beans |
| Nutritional acute postprandial intervention: Control glucoseVolunteers will arrive at fasting and capillary blood samples will be obtained before (0 min) and after the intake an amount of control glucose containing 50g of this monosscharide (10 min of intake), capillary slood will be also obtained at 15, 30, 60, 90 and 120 postprandial for glycemia determination. | Other | Glucose control |
Primary outcome
Change in the postprandial levels of methylglyoxal in plasma
Time frame: 0, 30, 60 and 120 min postprandial
Determiantion of the change in the levels of methylglyoxal in plasma by means of pre-column derivatization and posterior separation, detection and quantification by means of high performance liquid chromatography and detection by fluorescence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: No. This was not authorized by the Institutional Ethics Comitee
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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.
Felipe Ávila, PhD principal investigator
School of Nutrition and Dietetics, Health Sciences Faculty, University of Talca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional acute postprandial intervention: bread suppelmented with Chilean beans in people with Aging, run by University of Talca at 1 site in Chile.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 21 Jul 2023. 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 Chile. 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. 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?
Results are not available in the source record.
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?
Change in the postprandial levels of methylglyoxal in plasma (time frame: 0, 30, 60 and 120 min postprandial). 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 21 Jul 2023.