Clinical trial NCT02297074: Evaluation of Glycemic Index, Glycemic Load and Insulinemic Index of Spanish Breads
Official title: Evaluation of Glycemic Index Glycemic Load and Insulinemic Index of Spanish Breads and Their Effect on Incretins and Gastrointestinal Hormones Related With Appetite Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Bread
Glycemic index
Glycemic load
Insulinemic index
Satiety
Gastrointestinal hormones
Lead sponsor: Organización Interprofesional Agroalimentaria de Cereales Panificables y Derivados
Sponsor class: OTHER
Collaborators: name: Universidad de Granada
First posted: 2014-11-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The present study was carried out to determine the glycaemic index (GI), glycaemic load (GL), insulinaemic index (InI), appetite ratings and postprandial plasma concentrations of gastrointestinal hormones related to the control of food intake after the ingestion of five types of commercially available selected Spanish breads. All volunteers took the breads and glucose in a crossover interventional study.

Detailed description: The most important cereal-derived nourishment is bread, a staple food which is the main source of daily carbohydrates. White bread is the one for which the most rapid decline has occurred, probably due to a popular belief that bread provokes weight gain, but more studies are needed to clarify the relationship between bread consumption and ponderal status in Spanish population.

A growing body of evidence supports a beneficial role for low-glycaemic index (GI) and glycaemic load (GL) diets in the prevention of life style-related diseases such as type-2 diabetes. Likewise, GI s widely used in the selection of foods suitable for glycaemic control, since low to moderate GI diets have been proposed for the prevention of type 2 diabetes, cardiovascular disease and age-related eye diseases. On the contrary, related to obesity, no associations between BMI, GI and GL have been reported in a Mediterranean population. Thus, investigations focuses on the implication of glycaemic response of different breads are of important application.

Many factors such as manufacturing bread conditions, starch structure, bread particle size and inclusion of different types of ingredients like whole-grains may influence glycaemic response and therefore may contribute to modify GI, GL and InI of breads. Comparing different French breads, GI value varied between 57 for the traditional baguette and 85 for the wholemeal loaf, while the traditional baguette exerted a significantly lowest postprandial insulin response and the lowest InI. However, to our best knowledge, neither the influence of different types of Spanish breads on GI, GL and InI nor the effects on appetite ratings and on the postprandial gastrointestinal hormone responses have been investigated.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 45 years old
* body mass index (BMI) between 18 and 30, normal and overweight
* healthy
* Accept to participate in the study

Exclusion Criteria:

* age below 18 and more than 45 years old
* BMI lower than 18 and more than 29
* smokers
* pregnancy or breastfeeding
* unusual fibre consumption
* glucose plasma levels higher than 110 mg/dl
* insulin plasma levels higher than 10 mU/ml
* blood pressure higher than 110 mmHg
* medication to treat blood pressure glucose or lipid metabolism
* suffering from metabolic or gastrointestinal syndrome
* genetic dyslipidemia or intake nutritional supplements in the last three months

Primary outcomes:
measure: Postprandial determination of Glycemic index and glycemic load
timeFrame: from fasting to 180 mins after the intake of the breads
Secondary outcomes:
measure: Postprandial determination of Insulinemic index
timeFrame: from fasting to 180 mins after the intake of the breads
measure: Postprandial determination of Appetite profile
timeFrame: from fasting to 180 mins after the intake of the breads
measure: Postprandial determination of Plasma gastrointestinal hormone concentrations
timeFrame: from fasting to 180 mins after the intake of the breads
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Granada
name: MARÍA D MESA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Granada
name: ANGEL GIL, PROFESSOR
role: STUDY_DIRECTOR
References:
citation: Barclay AW, Petocz P, McMillan-Price J, Flood VM, Prvan T, Mitchell P, Brand-Miller JC. Glycemic index, glycemic load, and chronic disease risk--a meta-analysis of observational studies. Am J Clin Nutr. 2008 Mar;87(3):627-37. doi: 10.1093/ajcn/87.3.627.
citation: Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.