search
Back to results

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
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperglycemia

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 6, 2016
    Last Updated
    January 10, 2016
    Sponsor
    University of Turin, Italy
    search

    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

    Learn more about this trial

    Glycemic and Hormone Responses After the Intake of Four Types of Bread.

    We'll reach out to this number within 24 hrs