Evaluation of Glycemic Index, Glycemic Load and Insulinemic Index of Spanish Breads

Healthy Volunteers Clinical Trial

— BREADGI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297074
• Other study ID #: BreadGI
• Status: Completed
• Phase: N/A
• First received: October 31, 2014
• Last updated: November 18, 2014
• Start date: January 2013
• Est. completion date: August 2013

Study information

• Verified date: November 2014
• Source: Organización Interprofesional Agroalimentaria de Cereales Panificables y Derivados
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Ordinary white bread
The evening before the test day, subjects consumed a standardised dinner. Volunteers arrived in a 12-h fasting state. A fasting blood sample was acquired after the resting time, and appetite feelings were assessed by using visual analogue The subjects were instructed to consume the tested bread or 50 g of glucose. The subjects immediately completed two VAS, one on appetite feelings and another on bread palatability. The appetite feeling VAS were repeated every 30 min until a total of 180 min had passed. The subjects were not allowed to eat or drink anything else during the 180 min of the intervention. After the last blood extraction (3 h), an ad libitum lunch and 300 ml of water was provided. Volunteers ate until comfortably satisfied and the amount of food intake was registered
• Precooked-Frozen White Bread
The evening before the test day, subjects consumed a standardised dinner. Volunteers arrived in a 12-h fasting state. A fasting blood sample was acquired after the resting time, and appetite feelings were assessed by using visual analogue The subjects were instructed to consume the tested bread or 50 g of glucose. The subjects immediately completed two VAS, one on appetite feelings and another on bread palatability. The appetite feeling VAS were repeated every 30 min until a total of 180 min had passed. The subjects were not allowed to eat or drink anything else during the 180 min of the intervention. After the last blood extraction (3 h), an ad libitum lunch and 300 ml of water was provided. Volunteers ate until comfortably satisfied and the amount of food intake was registered
• Candeal-flour White Bread
The evening before the test day, subjects consumed a standardised dinner. Volunteers arrived in a 12-h fasting state. A fasting blood sample was acquired after the resting time, and appetite feelings were assessed by using visual analogue The subjects were instructed to consume the tested bread or 50 g of glucose. The subjects immediately completed two VAS, one on appetite feelings and another on bread palatability. The appetite feeling VAS were repeated every 30 min until a total of 180 min had passed. The subjects were not allowed to eat or drink anything else during the 180 min of the intervention. After the last blood extraction (3 h), an ad libitum lunch and 300 ml of water was provided. Volunteers ate until comfortably satisfied and the amount of food intake was registered
• Alfacar White Bread
The evening before the test day, subjects consumed a standardised dinner. Volunteers arrived in a 12-h fasting state. A fasting blood sample was acquired after the resting time, and appetite feelings were assessed by using visual analogue The subjects were instructed to consume the tested bread or 50 g of glucose. The subjects immediately completed two VAS, one on appetite feelings and another on bread palatability. The appetite feeling VAS were repeated every 30 min until a total of 180 min had passed. The subjects were not allowed to eat or drink anything else during the 180 min of the intervention. After the last blood extraction (3 h), an ad libitum lunch and 300 ml of water was provided. Volunteers ate until comfortably satisfied and the amount of food intake was registered
• Wholemeal Bread
The evening before the test day, subjects consumed a standardised dinner. Volunteers arrived in a 12-h fasting state. A fasting blood sample was acquired after the resting time, and appetite feelings were assessed by using visual analogue The subjects were instructed to consume the tested bread or 50 g of glucose. The subjects immediately completed two VAS, one on appetite feelings and another on bread palatability. The appetite feeling VAS were repeated every 30 min until a total of 180 min had passed. The subjects were not allowed to eat or drink anything else during the 180 min of the intervention. After the last blood extraction (3 h), an ad libitum lunch and 300 ml of water was provided. Volunteers ate until comfortably satisfied and the amount of food intake was registered
• Glucose
50 g of glucose were administered as a reference

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Organización Interprofesional Agroalimentaria de Cereales Panificables y Derivados	Universidad de Granada

References & Publications (2)

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. Review. — View 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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial determination of Glycemic index and glycemic load	Glycemic index is defined as the blood glucose response measured as AUC in response to a test food consumed by an individual under standard conditions related to the postprandial response to 50 g of oral glucose load under the same conditions.; Glycemic load takes into account the GI of the product and how many available carbohydrates are in a food serving and is calculated as GL = [GI of product/100 x g of available carbohydrates in a food serving]	from fasting to 180 mins after the intake of the breads	No
Secondary	Postprandial determination of Insulinemic index	insulinemic index measures the increment of insulin AUC over two hours in response to consumption of the amount of bread providing a 50 g of available carbohydrates divided by AUC after ingestion of 50 g of glucose after two hours	from fasting to 180 mins after the intake of the breads	No
Secondary	Postprandial determination of Appetite profile	Appetite profile was assessed using VAS ratings of hunger, fullness, desire to eat and prospective food consumption, based on a 100-mm scale ranging from 0 ("not at all") to 100 ("extremely"). This questionnaire was completed before and every 30 min during the 240 min following the intake of the breakfast. A validated composite appetite score was calculated using the following equation: Composite appetite score = (satiety + fullness + (l00 - prospective food consumption) + (100 - hunger))/4 (Flint et al., 2000).	from fasting to 180 mins after the intake of the breads	No
Secondary	Postprandial determination of Plasma gastrointestinal hormone concentrations	For the determination of gastrointestinal hormone plasma concentrations, whole blood was added to peptidase inhibitor, which are needed for the determination of some hormones. This blood sample was centrifuged at 1000 x g for 10 min at 4 ºC, divided into aliquots and frozen at -80ºC for analyses. Plasma concentrations of insulin, ghrelin, GLP-1, gastric inhibitory polypeptide (GIP), peptide YY (PYY) and pancreatic polypeptide (PP) were determined using a MILLIplexTM kit (Millipore, USA).	from fasting to 180 mins after the intake of the breads	No