Microstructure of starch-based meals and change in blood sugar
| ISRCTN | ISRCTN39636850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39636850 |
- Submission date
- 05/04/2019
- Registration date
- 23/04/2019
- Last edited
- 02/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
Avenida Libertador Bernardo O´Higgins 340
Santiago
8320000
Chile
 ORCID ID |
0000-0003-2895-0369 |
|---|---|
| Phone | +56 23543862 |
| jsantosm@uc.cl |
Study information
| Study design | Non-randomised crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | not available in web format, please use contact details to request a participant information cheet |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/07/2013 |
| Completion date | 30/12/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 8 |
| Total final enrolment | 8 |
| Key inclusion criteria | 1. Female 2. Normoglycemic 3. Normal weight Body Mass Index of 22 ± 1.9 kg/m2 (Mean ± SD) |
| Key exclusion criteria | 1. Family history of diabetes 2. Diabetes 3. Glucose intolerance 4. Dyslipidemia 5. Pregnant |
| Date of first enrolment | 05/03/2015 |
| Date of final enrolment | 30/08/2015 |
Locations
Countries of recruitment
- Chile
Study participating centre
Santiago
8320000
Chile
Sponsor information
University/education
Avenida Libertador Bernardo O´higgins 340
Santiago
8320000
Chile
| Phone | +56 23543862 |
|---|---|
| jsantosm@uc.cl | |
| Website | http://www.uc.cl |
"ROR" |
https://ror.org/04teye511 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Fund for Scientific and Technological Development, El Fondo Nacional de Desarrollo Científico y Tecnológico, FONDECYT
- Location
- Chile
Results and Publications
| Intention to publish date | 15/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/11/2019 | 02/12/2019 | Yes | No |
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.
