Healthy VolunteersBREADGINCT02297074
Evaluation of Glycemic Index, Glycemic Load and Insulinemic Index of Spanish Breads
A study testing Ordinary white bread, Precooked-Frozen White Bread and Candeal-flour White Bread in people with Healthy Volunteers, run by Organización Interprofesional Agroalimentaria de Cereales Panificables y Derivados.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Ordinary white bread, Precooked-Frozen White Bread and Candeal-flour White Bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Ordinary white bread, Precooked-Frozen White Bread, Candeal-flour White Bread, Alfacar White Bread, Wholemeal Bread
- Keywords
- Bread, Glycemic index, Glycemic load, Insulinemic index, Satiety, Gastrointestinal hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ordinary white breadOther
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 BreadOther
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 BreadOther
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 BreadOther
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 BreadOther
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
GlucoseOther
50 g of glucose were administered as a reference
| Study group | Role | What they receive |
|---|---|---|
| Ordinary White Bread | Experimental | Ordinary white bread bread is characterised by a white crumb with regular soft alveoli and a slightly soft thin crust. Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Wholemeal Bread |
| Glucose | Active comparator | Glucose is used to calculate glycemic index, glycemic load and insulinemic index Receives: Other: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: from fasting to 180 mins after the intake of the breads
Secondary outcomes (3)
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
Measured: from fasting to 180 mins after the intake of the breads
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).
Measured: from fasting to 180 mins after the intake of the breads
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).
Measured: from fasting to 180 mins after the intake of the breads
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startJan 2013
- Primary completionApr 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organización Interprofesional Agroalimentaria de Cereales Panificables y Derivados
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Granada
- Responsible party
- Sponsor
- Investigators
- MARÍA D MESA, PhD, Principal investigator, Universidad de GranadaANGEL GIL, PROFESSOR, Study director, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297074
- Sponsor's protocol ID
- BreadGI
- Acronym
- BREADGI
- Status last verified
- Nov 2014
- First submitted
- 31 Oct 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18326601Blundell 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.
PubMed 20122136
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02297074
- Acronym / sponsor ID
- BREADGI / BreadGI
- Conditions
- Healthy Volunteers
- Keywords
- Bread, Glycemic index, Glycemic load, Insulinemic index, Satiety, Gastrointestinal hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Organización Interprofesional Agroalimentaria de Cereales Panificables y DerivadosUniversity, hospital or other
- Collaborators
- Universidad de Granada
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Ordinary White Bread | Experimental | Other: Ordinary white breadOrdinary white bread bread is characterised by a white crumb with regular soft alveoli and a slightly soft thin crust. |
| Precooked-Frozen White Bread | Experimental | Other: Precooked-Frozen White BreadPrecooked-Frozen white bread is characterized by white crumb with regular soft alveoli and bright crusty crust |
| Candeal-flour White Bread | Experimental | Other: Candeal-flour White BreadCandeal-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 |
| Alfacar White Bread | Experimental | Other: Alfacar White BreadAlfacar 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 |
| Organic Wholemeal Bread | Experimental | Other: Wholemeal BreadThe 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 |
| Glucose | Active comparator | Other: GlucoseGlucose is used to calculate glycemic index, glycemic load and insulinemic index |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- age below 18 and more than 45 years old
- BMI lower than 18 and more than 29
- smokers
- pregnancy or breastfeeding
- unusual fibre consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ordinary white breadThe 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 | Other | Ordinary White Bread |
| Precooked-Frozen White BreadThe 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 | Other | Precooked-Frozen White Bread |
| Candeal-flour White BreadThe 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 | Other | Candeal-flour White Bread |
| Alfacar White BreadThe 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 | Other | Alfacar White Bread |
| Wholemeal BreadThe 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 | Other | Organic Wholemeal Bread |
| Glucose50 g of glucose were administered as a reference | Other | Glucose |
Primary outcome
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]
3 secondary outcomes
Postprandial determination of Insulinemic index
Time frame: from fasting to 180 mins after the intake of the breads
Postprandial determination of Appetite profile
Time frame: from fasting to 180 mins after the intake of the breads
Postprandial determination of Plasma gastrointestinal hormone concentrations
Time frame: from fasting to 180 mins after the intake of the breads
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
- Results publication: PubMed 18326601Barclay 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.
- Results publication: PubMed 20122136Blundell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARÍA D MESA, PhD principal investigator
Universidad de Granada
ANGEL GIL, PROFESSOR study director
Universidad de Granada
Questions about this trial
What is this clinical trial studying?
A study testing Ordinary white bread, Precooked-Frozen White Bread and Candeal-flour White Bread in people with Healthy Volunteers, run by Organización Interprofesional Agroalimentaria de Cereales Panificables y Derivados.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial determination of Glycemic index and glycemic load (time frame: from fasting to 180 mins after the intake of the breads). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02297074, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.