Plain English Summary
Background and study aims
The postprandial glycemic response (response after consuming food) consists of the elevation of blood sugar (glucose) levels that occur after the ingestion of carbohydrate-rich foods. It has been shown that there is great variability in the postprandial response in response to the intake of different foods. Starch is the most abundant source of carbohydrates of vegetable origin. The main objective of the study was to evaluate if the physical properties of solid foods based on starch, gluten and lipids are associated with different postprandial glycemia/insulin responses in response to the intake of starchy foods (starch test and glucose test oral).
Who can participate?
Healthy female volunteers of normal weight, the participants were selected from previous studies.
What does the study involve?
Visit the centre on four occasions one week apart after 8-12 hours of fasting (only water allowed). During the first visit, basic measurements are performed including a blood test. During the second visit, participants have multiple blood tests after eating a small amount. During the third and fourth visit, further meal tests were performed
What are the possible benefits and risks of participating?
Benefits: Participants will not benefit from participating in this biomedical research.However, they may know what their current nutritional status is and their blood sugar and lipid tests. They were given a written document containing general nutritional recommendations and prevention of diabetes mellitus, made by a nutrition professional. If the results of the oral glucose tolerance test were altered, they were given medical advice in this regard
Risks: The extraction of blood can cause pain, bruising, bruising and rarely infection at the puncture site. In the procedures involving several blood samples, only one puncture was performed, obtaining the samples from the same route. To avoid this type of discomfort to the maximum the person who extracted the blood sample had great experience in the procedure
Where is the study run from?
UC Centre of Clinical Research, Santiago, Chile
When is the study starting and how long is it expected to run for?
March 2015 to December 2016
Who is funding the study?
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile.
Supported by a FONDECYT grant (1170594) for J. Parada, and a FONDECYT grant (1150416) for J.L. Santos.
Who is the main contact?
Dr. José Luis Santos, jsantosm@uc.cl
Trial website
Contact information
Type
Scientific
Primary contact
Dr José Luis Santos
ORCID ID
http://orcid.org/0000-0003-2895-0369
Contact details
Avenida Libertador Bernardo O´Higgins 340
Santiago
8320000
Chile
+56 23543862
jsantosm@uc.cl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Microstructure of starch-based meals with either palm or soybean oils alter in vitro starch digestibility with no major effects on glycemic responses
Acronym
Study hypothesis
Study the effects of the oil type in a solid ternary matrix (starch-oil-protein) on starch digestibility. Additionally, we studied the postprandial glycemic responses to starch-based meals enriched with either palm or soybean oil in volunteers in a pilot study.
Ethics approval
Approved 16/10/2014, Ethics Committee of the School of Medicine of the Pontificia Universidad Católica de Chile (Marcoleta 391, Piso 1, 8330024, Santiago, Chile; 02-2354.8173; etica.investigacion@med.puc.cl), ref: 14-479
Study design
Non-randomised crossover trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Other
Patient information sheet
not available in web format, please use contact details to request a participant information cheet
Condition
Healthy volunteers
Intervention
Participants visited the UC Centre of Clinical Research in four occasions one week apart after 8-12 hours of fasting (only water was allowed). During the first visit, basal biochemical and anthropometric measurements were performed. At this stage, subjects with diabetes, glucose intolerance, dyslipidemia or in pregnancy were excluded from the study. During the second visit, participants were submitted to a standard 75g Oral Glucose Tolerance Test (OGTT). Blood samples were drawn at -15, -5, 15, 30, 60, 90 and 120 minutes after glucose ingestion. During the third and fourth visit, meal tests were performed with model solid meals based on starch, wheat gluten and two types of triglycerides based on either palm or soybean oil, which have notable differences in the fraction of palmitic and linoleic acids. The meal consisted of 140 g of a dough containing 25 g of potato starch, 5 g of wheat gluten and 5.7 g of oils (either palm or soybean oil). Each meal was consumed together with 150 mL of tap-water over, at most, five minutes by chewing approximately 15 times before swallowing.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Plasma glucose, insulin levels and c-peptide, measured by blood sample analysis at -15, -5, 15, 30, 60, 90, and 120 minutes after glucose ingestion and meal test.
Secondary outcome measures
1. Glycemic response after meal tests measured by drawing of blood samples at times -15, -5, 15, 30, 60, 90, and 120 minutes after meal test, for the determination of plasma glucose and insulin levels.
2. Anthropometric and biochemical characteristics measured after 8-12 hours of fasting:
2.1 Age (years)
2.2 Weight (kg)
2.3 Height (m)
2.4 BMI (kg/m²)
2.5 Fasting Glucose (mg/dl)
2.6 Fasting Insulin (μIU/ml)
2.7 Total cholesterol (mg/dL)
2.8 HDL cholesterol (mg/dL)
2.9 Triglycerides (mg/dL)
2.10 Systolic arterial pressure (mmHg)
2.11 Diastolic blood pressure (mmHg)
The anthropometric measurements were made by personnel trained in light clothing and without shoes, using a calibrated set of stadiometers, scales and tapes. The weight and height were used to calculate the BMI (Kg / m2). Fasting blood samples were taken in the volunteers, and blood glucose, insulinemia, total cholesterol, HDL cholesterol and triglycerides were measured by the laboratory of the Department of Nutrition, Diabetes and Metabolism of the Pontificia Universidad Catolica de Chile
Overall trial start date
15/07/2013
Overall trial end date
30/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female
2. Normoglycemic
3. Normal weight Body Mass Index of 22 ± 1.9 kg/m2 (Mean ± SD)
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
8
Total final enrolment
8
Participant exclusion criteria
1. Family history of diabetes
2. Diabetes
3. Glucose intolerance
4. Dyslipidemia
5. Pregnant
Recruitment start date
05/03/2015
Recruitment end date
30/08/2015
Locations
Countries of recruitment
Chile
Trial participating centre
UC Centre of Clinical Research
Portugal 61
Santiago
8320000
Chile
Sponsor information
Organisation
Pontificia Universidad Católica de Chile
Sponsor details
Avenida Libertador Bernardo O´higgins 340
Santiago
8320000
Chile
+56 23543862
jsantosm@uc.cl
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Fondo Nacional de Desarrollo Científico y Tecnológico
Alternative name(s)
El Fondo Nacional de Desarrollo Científico y Tecnológico, National Fund for Scientific and Technological Development, FONDECYT
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Chile
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
15/06/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in https://doi.org/10.1080/09637486.2019.1693521 (added 02/12/2019)