Glycemic and Hormone Responses After the Intake of Four Types of Bread.
Primary Purpose
Hyperglycemia, Insulin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intake of the specific kind of bread
Sponsored by
About this trial
This is an interventional prevention trial for Hyperglycemia
Eligibility Criteria
Inclusion Criteria:
- body mass index (BMI) between 18 and 25 kg/m2
- healthy
- Accept to participate in the study
Exclusion Criteria:
- smokers
- subjects suffering from any diseases
- drug therapy
- dietary supplementation
- patients unable to give informed consent to participate in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
commercial bread, wheat flour
wheat, organic flour
wheat, supermarket flour
einkorn, organic flour
Arm Description
Intake of the specific kind of bread
Intake of the specific kind of bread
Intake of the specific kind of bread
intake of the specific kind of bread
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02653677
First Posted
January 6, 2016
Last Updated
January 10, 2016
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT02653677
Brief Title
Glycemic and Hormone Responses After the Intake of Four Types of Bread.
Official Title
Glycemic and Hormone Responses and Satiety After the Intake of Four Types of Bread.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Insulin Sensitivity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
commercial bread, wheat flour
Arm Type
Active Comparator
Arm Description
Intake of the specific kind of bread
Arm Title
wheat, organic flour
Arm Type
Experimental
Arm Description
Intake of the specific kind of bread
Arm Title
wheat, supermarket flour
Arm Type
Experimental
Arm Description
Intake of the specific kind of bread
Arm Title
einkorn, organic flour
Arm Type
Experimental
Arm Description
intake of the specific kind of bread
Intervention Type
Other
Intervention Name(s)
intake of the specific kind of bread
Intervention Description
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
Primary Outcome Measure Information:
Title
Glucose-under-the curve (AUC) after ingestion of 4 types of bread
Description
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
Time Frame
0 to 120 minutes after the ingestion of each bread
Secondary Outcome Measure Information:
Title
Insulin-under-the curve (AUC) after ingestion of 4 types of bread
Description
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
Time Frame
0 to 120 minutes after the ingestion of each bread
Other Pre-specified Outcome Measures:
Title
Free fatty acid (FFA) AUC after the ingestion of 4 types of bread
Description
FFA AUC is defined as the variation in FFA concentrations in response to the consumption of the amount of bread providing 50 g of available carbohydrates
Time Frame
0 to 120 minutes after the ingestion of each bread
Title
Ghrelin responses after the ingestion of 4 types of bread
Description
Ghrelin AUC is defined as the variation in ghrelin concentrations in response to the consumption of the amount of bread providing 50 g of available carbohydrates
Time Frame
0 to 120 minutes after the ingestion of each bread
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
body mass index (BMI) between 18 and 25 kg/m2
healthy
Accept to participate in the study
Exclusion Criteria:
smokers
subjects suffering from any diseases
drug therapy
dietary supplementation
patients unable to give informed consent to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simona Bo, MD
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Glycemic and Hormone Responses After the Intake of Four Types of Bread.
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