Bread Supplemented With Chilean Beans to Decrease Postprandial Glycoxidative Responses: A Pilot Intervention

NCT05955131 | Unknown

• 1 other identifier: CIES 002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Aging

Keywords

Oxidative stress; Glycoxidation; Advanced glycation end products; Aging; Bread; Antioxidants; Fiber; Platelet aggregation

Outcome Measures

Primary Outcomes (1)

• 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

  0, 30, 60 and 120 min postprandial

Study Arms (3)

Control Bread

OTHER

Subjects will eat control bread, in an amount containing 50g of carbohydrates

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

Other: Nutritional acute postprandial intervention: bread suppelmented with Chilean beans

Glucose control

OTHER

Subjects will drink glucose, in an amount containing 50g of carbohydrates

Other: Nutritional acute postprandial intervention: Control glucose

Interventions

Nutritional acute postprandial intervention: Control bread OTHER

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

Control Bread

Nutritional acute postprandial intervention: bread suppelmented with Chilean beans OTHER

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.

Bread Supplemented with Chilean Beans

Nutritional acute postprandial intervention: Control glucose OTHER

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.

Glucose control

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Talca: lead
• Interuniversity Center for Healthy Aging: collaborator
• Centro de Estudios en Alimentos Procesados: collaborator
• Clínica Fleming de Talca: collaborator

Study Sites (1)

School of Nutrition and Dietetics

Talca, 3460000, Chile

Location

Study Officials

• Felipe Ávila, PhD

  School of Nutrition and Dietetics, Health Sciences Faculty, University of Talca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Blood samples will be codified, and the keys will be saved by Felipe Ávila. The personal in charge of the blood analyses (quantification of methylglyoxal and 3-deoxyglucosone) will register their results using the codes and therefore will not know the type of sample analyzing or the volunteer that provided the sample.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asociate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 21, 2023
• Study Start: May 5, 2023
• Primary Completion: May 30, 2023
• Study Completion: April 30, 2024
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)