NCT02297074

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

3 months

First QC Date

October 31, 2014

Last Update Submit

November 18, 2014

Conditions

Keywords

BreadGlycemic indexGlycemic loadInsulinemic indexSatietyGastrointestinal hormones

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Postprandial determination of Insulinemic index

    from fasting to 180 mins after the intake of the breads

  • Postprandial determination of Appetite profile

    from fasting to 180 mins after the intake of the breads

  • Postprandial determination of Plasma gastrointestinal hormone concentrations

    from fasting to 180 mins after the intake of the breads

Study Arms (6)

Ordinary White Bread

EXPERIMENTAL

Ordinary white bread bread is characterised by a white crumb with regular soft alveoli and a slightly soft thin crust.

Other: Ordinary white bread

Precooked-Frozen White Bread

EXPERIMENTAL

Precooked-Frozen white bread is characterized by white crumb with regular soft alveoli and bright crusty crust

Other: Precooked-Frozen White Bread

Candeal-flour White Bread

EXPERIMENTAL

Candeal-flour white bread has a thick crust of between one and two millimetres, which is smooth and crisp, golden to light brown in colour and which tastes of toasted cereal. The crumb of the bread is white and its texture is smooth, spongy and consistent, with little regular alveolus and with an intense cereal aroma with a pleasant and slightly sweet taste

Other: Candeal-flour White Bread

Alfacar White Bread

EXPERIMENTAL

Alfacar white bread is made according to its protected designation of origin and protected geographical indication (D.O. Alfacar, Granada, Spain). The bread has a creamy white, flexible and soft crumb, with many randomly scattered holes. The crust is medium-thick to thick, golden, slightly shiny and quite smooth

Other: Alfacar White Bread

Organic Wholemeal Bread

EXPERIMENTAL

The Organic wholemeal bread only includes organic whole grain flours as the unique difference compared with the Ordinary bread. The resulting dark brown bread is characterized by compact crumb free of alveoli and hard thin crust

Other: Wholemeal Bread

Glucose

ACTIVE COMPARATOR

Glucose is used to calculate glycemic index, glycemic load and insulinemic index

Other: Glucose

Interventions

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

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

Organic Wholemeal Bread
GlucoseOTHER

50 g of glucose were administered as a reference

Glucose

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1093/ajcn/87.3.627.

  • 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.

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • MARÍA D MESA, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR
  • ANGEL GIL, PROFESSOR

    Universidad de Granada

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 21, 2014

Study Start

January 1, 2013

Primary Completion

April 1, 2013

Study Completion

August 1, 2013

Last Updated

November 21, 2014

Record last verified: 2014-11