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Completed

NCT Number: NCT02297074

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ordinary white bread

Other

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

Other

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

Other

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

Other

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

Other

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

Other

50 g of glucose were administered as a reference

Primary outcomes

  1. Postprandial determination of Glycemic index and glycemic load

    Time frame: from fasting to 180 mins after the intake of the breads

    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]

Secondary outcomes

  1. Postprandial determination of Insulinemic index

    Time frame: from fasting to 180 mins after the intake of the breads

    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

  2. Postprandial determination of Appetite profile

    Time frame: from fasting to 180 mins after the intake of the breads

    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).

  3. Postprandial determination of Plasma gastrointestinal hormone concentrations

    Time frame: from fasting to 180 mins after the intake of the breads

    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).

Sponsors and collaborators

Lead sponsor

Organización Interprofesional Agroalimentaria de Cereales Panificables y Derivados

Other

Collaborators

  • Universidad de Granada

Registry information

Official study 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

Acronym: BREADGI

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2014
Registry last updated
Nov 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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