Effectiveness of Carbohydrate Counting Method With Mixed Meals

October 8, 2016 updated by: Aimilia Papakonstantinou, Agricultural University of Athens

Effectiveness of the Carbohydrate Counting Method on Postprandial Glucose Concentrations After Consumption of Mixed Meals in Adults With Type 1 Diabetes

In a randomized, cross-over designed study, the investigators examined the effectiveness of the carbohydrate counting method after consumption of mixed meals typical of the Greek cuisine with various protein and fat contents in a sample of people with type 1 diabetes (DM1). The investigators also tried to further explore the effects of additional extra virgin olive oil (11 ml) on the glycemic response.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total of 20 adults with type 1 diabetes on intensive insulin therapy consumed three mixed meals at noon between 1200 and 1300 hours, with and without the addition of 11 ml extra virgin oil, in random order. One week before entering the study, participants kept a detailed 7-day weighed food record with fingerprick blood glucose measurements pre-and-2hour post-meals for calculation of their carbohydrate (g) to insulin (units) ratio. Moreover, the individual correction factor was calculated. Thereafter, insulin requirements for the test meals were calculated based on the carbohydrate content of each dish and according to the personalised carbohydrate to insulin ratio. Postprandial glycemia was measured in capillary blood glucose samples at 30min intervals over 195min. For 24hr before each testing session, participants were asked to refrain from the consumption of alcohol and to maintain their usual physical activity pattern. On the day of testing, subjects were asked to consume their usual breakfast and abstain from food for at least 2 hours before their appointment. If blood glucose was >7.2 mmol/l at 1200, insulin was administered based on the individualised correction factor. If blood glucose was >10 mmol/l at the beginning of the testing session, insulin was administered to correct it and the subject was asked to return on another day. if hypoglycaemia occurred (defined as blood glucose level <3.8 mmol/l), the test session was stopped, the event was recorded and the patient treated appropriately. The on target 2hour postprandial blood glucose level was set between 3.9 and 10 mmol/l. Anthropometric measurements (body weight, waist and hip circumferences) were performed at every visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with type 1 diabetes
  • Intensive insulin therapy
  • HbA1c < 10%
  • >2 years with diabetes

Exclusion Criteria:

  • Food allergies
  • Diabetic neuropathy
  • Kidney disease
  • Hematological disturbances
  • Liver disease
  • Uncontrolled hypo- or hyperthyroidism
  • Arrhythmia
  • Heart disease
  • Cancer
  • Serious mental illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mixed meal 1
20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) <10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.
Other: Mixed meal 1
20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed a dish made with thick pasta, minced meat and béchamel sauce and 20 g kalamata olives. The meal provided 794 kcal and contained approximately 500 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
Experimental: Mixed meal 2
20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) <10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.
Other: Mixed meal 2
20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed grilled chicken with vegetables.The meal provided 399 kcal and contained approximately 300 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
Experimental: Mixed meal 3
20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) <10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.
Other: Mixed meal 3
20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed baked giant beans and 20g kalamata olives. The meal provided 502 kcal and contained approximately 300 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
Experimental: Mixed meal 4
20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) <10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.
Other: Mixed meal 4
20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed a dish made with thick pasta, minced meat and béchamel sauce and 20 g kalamata olives and 11 ml extra virgin olive oil. The meal provided 893 kcal and contained approximately 600 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
Experimental: Mixed meal 5
20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) <10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.
Other: Mixed meal 5
20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed grilled chicken with vegetables and 11 ml extra virgin olive oil. The meal provided 497 kcal and contained approximately 300 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
Experimental: Mixed meal 6
20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) <10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.
Other: Mixed meal 6
20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed baked giant beans and 20 g kalamata olives and 11 ml extra virgin olive oil. The meal provided 601 kcal and contained approximately 400 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Capillary blood glucose
Time Frame: 195 minutes
Clinically useful change in capillary blood glucose, defined as the restoration of glucose within normal limits during the first two hours and until the end of the trial
195 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Agricultural University of Athens

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harokopio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRBD 11th Session 6/4/2014 NHA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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