HyperglycemiaNCT02653677
Glycemic and Hormone Responses After the Intake of Four Types of Bread.
A study testing intake of the specific kind of bread in people with Hyperglycemia and Insulin Sensitivity, run by University of Turin, Italy.
Trial summary
The purposes of the present study are to determine the glycemic and insulinemic responses, the satiety rate and the postprandial plasma concentrations of free fatty acids, triglycerides and satiety hormones after the ingestion of four types of breads: handcrafted bread made with wheat organic flour; handcrafted bread… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Insulin Sensitivity
- What is being tested?
- intake of the specific kind of bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jul 2015
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index (BMI) between 18 and 25 kg/m2
- healthy
- Accept to participate in the study
Who cannot join
- smokers
- subjects suffering from any diseases
- drug therapy
- dietary supplementation
- patients unable to give informed consent to participate in the study
About this study
Official title: Glycemic and Hormone Responses and Satiety After the Intake of Four Types of Bread.
The purposes of the present study are to determine the glycemic and insulinemic responses, the satiety rate and the postprandial plasma concentrations of free fatty acids, triglycerides and satiety hormones after the ingestion of four types of breads: handcrafted bread made with wheat organic flour; handcrafted bread with wheat flour of large-scale retail distribution; handcrafted bread with organic einkorn flour and a commercial wheat bread.
Read the detailed description
The postprandial blood glucose concentration appears to play a critical role in the development of diabetes and cardiovascular diseases; it is largely influenced by the carbohydrate load of a meal. Thus, advocating carbohydrate (CHO) foods that promote favorable glycemic and insulinemic responses, with maintenance of satiety high over a longer period, may be a beneficial approach against many chronic diseases.
Bread is a basic food in Italian feeding. The industrial production of bread is gradually replacing the craft production by small bakeries. It is possible to buy daily bread obtained by completing baking carried out directly at the point of sale from pre-cooked and frozen dough. The use of "improver" as enzyme preparations such as alpha-amylase, improves the quality of bread. A study has found that trestatin, an amylase inhibitor incorporated into bread, produced lower glycemic and insulinemic responses; another has reported that bread made from the ancient wheat Einkorn (Triticum monococcum) elicited a reduced production of glucose-dependent insulinotrophic polypeptide (GIP).
The objectives of the present study are to determine the glycemic and insulinemic responses (area-under the curve, AUCs), the satiety rate and the AUCs of free fatty acids (FFA), triglycerides and ghrelin after the ingestion of four types of breads, each containing 50g of available CHO:
- 97 g handcrafted bread made with wheat organic flour;
- 97 g handcrafted bread with wheat flour of large-scale retail distribution;
- 94 g handcrafted bread with organic einkorn flour
- 86 g commercial precooked-frozen white bread. 16 healthy volunteers participated to this randomized cross-over trial. Each participant consumed the specific portion of a type of bread in the morning, after 8-12 h fasting. The other 3 types of bread are consumed by participants in the order determined by the randomization procedure, after a week each other.
At enrollment, all participants meet the inclusion criteria (see below). Nutrition and exercise advices are given for the day before each bread test. Participants should consume the bread portion in 15 minutes.
Blood samples are drawn every 30-min from fasting until 120-min after bread consumption. The following variables are evaluated at each time point: glucose, insulin, FFA, triglycerides, acylated ghrelin. The satiety rate is estimated every 30-min by the Satiety Labeled Intensity Magnitude scales.
- Conditions
- Hyperglycemia, Insulin Sensitivity
- Being tested
- intake of the specific kind of bread
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intake of the specific kind of breadOther
To determine the glycemic and insulinemic responses (area-under the curve, AUCs), the satiety rate and the AUCs of free fatty acids (FFA), triglycerides and ghrelin after the ingestion of four types of breads, each containing 50g of available carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| commercial bread, wheat flour | Active comparator | Intake of the specific kind of bread Receives: Other: intake of the specific kind of bread |
| wheat, organic flour | Experimental | Intake of the specific kind of bread Receives: Other: intake of the specific kind of bread |
| wheat, supermarket flour | Experimental | Intake of the specific kind of bread Receives: Other: intake of the specific kind of bread |
| einkorn, organic flour | Experimental | intake of the specific kind of bread Receives: Other: intake of the specific kind of bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose-under-the curve (AUC) after ingestion of 4 types of bread
Glycemic AUC is defined as the blood glucose increment over 2 hours in response to the consumption of the amount of bread providing 50 g of available carbohydrates
Measured: 0 to 120 minutes after the ingestion of each bread
Secondary outcomes (1)
Insulin-under-the curve (AUC) after ingestion of 4 types of bread
Insulinemic AUC is defined as the blood insulin increment over 2 hours in response to the consumption of the amount of bread providing 50 g of available carbohydrates
Measured: 0 to 120 minutes after the ingestion of each bread
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Bo, University of Turin, Italy
- Investigators
- Simona Bo, MD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653677
- Sponsor's protocol ID
- Bo11/14
- Status last verified
- Jan 2016
- First submitted
- 6 Jan 2016
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic and Hormone Responses and Satiety After the Intake of Four Types of Bread.
- ClinicalTrials.gov ID
- NCT02653677
- Acronym / sponsor ID
- Bo11/14
- Conditions
- Hyperglycemia, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Jan 2016 (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 purposes of the present study are to determine the glycemic and insulinemic responses, the satiety rate and the postprandial plasma concentrations of free fatty acids, triglycerides and satiety hormones after the ingestion of four types of breads: handcrafted bread made with wheat organic flour; handcrafted bread with wheat flour of large-scale retail distribution; handcrafted bread with organic einkorn flour and a commercial wheat bread.
Detailed description
The postprandial blood glucose concentration appears to play a critical role in the development of diabetes and cardiovascular diseases; it is largely influenced by the carbohydrate load of a meal. Thus, advocating carbohydrate (CHO) foods that promote favorable glycemic and insulinemic responses, with maintenance of satiety high over a longer period, may be a beneficial approach against many chronic diseases.
Bread is a basic food in Italian feeding. The industrial production of bread is gradually replacing the craft production by small bakeries. It is possible to buy daily bread obtained by completing baking carried out directly at the point of sale from pre-cooked and frozen dough. The use of "improver" as enzyme preparations such as alpha-amylase, improves the quality of bread. A study has found that trestatin, an amylase inhibitor incorporated into bread, produced lower glycemic and insulinemic responses; another has reported that bread made from the ancient wheat Einkorn (Triticum monococcum) elicited a reduced production of glucose-dependent insulinotrophic polypeptide (GIP).
The objectives of the present study are to determine the glycemic and insulinemic responses (area-under the curve, AUCs), the satiety rate and the AUCs of free fatty acids (FFA), triglycerides and ghrelin after the ingestion of four types of breads, each containing 50g of available CHO:
- 97 g handcrafted bread made with wheat organic flour;
- 97 g handcrafted bread with wheat flour of large-scale retail distribution;
- 94 g handcrafted bread with organic einkorn flour
- 86 g commercial precooked-frozen white bread. 16 healthy volunteers participated to this randomized cross-over trial. Each participant consumed the specific portion of a type of bread in the morning, after 8-12 h fasting. The other 3 types of bread are consumed by participants in the order determined by the randomization procedure, after a week each other.
At enrollment, all participants meet the inclusion criteria (see below). Nutrition and exercise advices are given for the day before each bread test. Participants should consume the bread portion in 15 minutes.
Blood samples are drawn every 30-min from fasting until 120-min after bread consumption. The following variables are evaluated at each time point: glucose, insulin, FFA, triglycerides, acylated ghrelin. The satiety rate is estimated every 30-min by the Satiety Labeled Intensity Magnitude scales.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| commercial bread, wheat flour | Active comparator | Other: intake of the specific kind of breadIntake of the specific kind of bread |
| wheat, organic flour | Experimental | Other: intake of the specific kind of breadIntake of the specific kind of bread |
| wheat, supermarket flour | Experimental | Other: intake of the specific kind of breadIntake of the specific kind of bread |
| einkorn, organic flour | Experimental | Other: intake of the specific kind of breadintake of the specific kind of bread |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- body mass index (BMI) between 18 and 25 kg/m2
- healthy
- Accept to participate in the study
Key exclusion criteria (5 listed)
- smokers
- subjects suffering from any diseases
- drug therapy
- dietary supplementation
- patients unable to give informed consent to participate in the study
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 |
|---|---|---|
| intake of the specific kind of breadTo determine the glycemic and insulinemic responses (area-under the curve, AUCs), the satiety rate and the AUCs of free fatty acids (FFA), triglycerides and ghrelin after the ingestion of four types of breads, each containing 50g of available carbohydrates | Other | commercial bread, wheat flour, einkorn, organic flour, wheat, organic flour, wheat, supermarket flour |
Primary outcome
Glucose-under-the curve (AUC) after ingestion of 4 types of bread
Time frame: 0 to 120 minutes after the ingestion of each bread
Glycemic AUC is defined as the blood glucose increment over 2 hours in response to the consumption of the amount of bread providing 50 g of available carbohydrates
1 secondary outcome
Insulin-under-the curve (AUC) after ingestion of 4 types of bread
Time frame: 0 to 120 minutes after the ingestion of each bread
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 12 Jan 2016.
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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.
Simona Bo, MD principal investigator
University of Turin, Italy
Questions about this trial
What is this clinical trial studying?
A study testing intake of the specific kind of bread in people with Hyperglycemia and Insulin Sensitivity, run by University of Turin, Italy.
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 3 inclusion and 5 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 12 Jan 2016. 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?
Glucose-under-the curve (AUC) after ingestion of 4 types of bread (time frame: 0 to 120 minutes after the ingestion of each bread). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2016.