Condition category
Not Applicable
Date applied
05/04/2019
Date assigned
23/04/2019
Last edited
02/12/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

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

http://www.uc.cl

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)

Publication citations

Additional files

Editorial Notes

02/12/2019: The following changes have been made: 1. Publication reference added. 2. The final enrolment number has been added from the reference. 29/08/2019: Internal review.