Microstructure of starch-based meals and change in blood sugar

ISRCTN	ISRCTN39636850
DOI	https://doi.org/10.1186/ISRCTN39636850
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Pontificia Universidad Católica de Chile
Funder	Fondo Nacional de Desarrollo Científico y Tecnológico

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr José Luis Santos
Scientific

Avenida Libertador Bernardo O´Higgins 340
Santiago
8320000
Chile

ORCID ID	0000-0003-2895-0369
Phone	+56 23543862
Email	jsantosm@uc.cl

Study information

Primary study design	Interventional
Study design	Non-randomised crossover trial
Secondary study design	Non randomised study
Study type	Participant information sheet
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	30/12/2016

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Female
Target sample size at registration	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

UC Centre of Clinical Research

Portugal 61
Santiago
8320000
Chile

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.