Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05955131 |
| Other study ID # |
CIES 002 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 2023 |
| Est. completion date |
April 30, 2024 |
Study information
| Verified date |
July 2023 |
| Source |
University of Talca |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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:
1. 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.
2. 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.
