Does Protein and Fat Content of Meal Increase Glucose Concentrations

November 2, 2017 updated by: Neşe Kaya, TC Erciyes University

Does High-Protein High-Fat Meal Increase Postprandial Glucose Concentrations and Meal-Time Insulin Requirements in Patients With Type 1 Diabetes on Basal-Bolus Insulin Regimen: A Randomized Controlled Trial

The study investigated the effects of fat protein counting (CFP) in addition to carbohydrate (CARB) counting for calculating prandial insulin dosage on blood glucose profile in patients with type 1 diabetes (T1D) on basal-bolus insulin therapy.

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

In this single center, crossover, randomized, controlled study, control meal (SM: standard meal using carbohydrate counting method) and three test meals (HPM: high protein meal using carbohydrate counting method, HPFM-a: high protein-fat meal using carbohydrate counting method and HPFM-b: high protein-fat meal using carbohydrate and fat-protein counting method) were compared on postprandial early (0-120 minutes), late (120-240 minutes) and total (0-240 minutes) glucose response.

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.
30

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

16 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects:

  • had Type1 Diabetes for at least 1 years;
  • use multiple dose (basal-bolus) insulin therapy;
  • use fast-acting insulin analogs (lispro, glulisine, and aspart) and basal insulin analogs (detemir, glargine);
  • daily inslin dose ≥0.5 IU/kg/day.

Exclusion Criteria:

Subjects:

  • had any restrictive food intake disorders (eg celiac disease or food allergy);
  • had any diabetes complications (eg neuropathy, nephropathy or retinopathy);
  • diagnosed for <1 year;
  • were using corticosteroid or any medication that could effect gastric emptying;
  • did exercise or had hypoglycemia or ketoacidosis within 24 hour before the test meals;
  • had overweight or obese (BMI z score: ≥ 1SD and ≥ 2SD respectively);
  • had not on follicular or peri-ovulatory phases of their menstrual cycles (for females).

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: Treatment
  • 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: Insulin dose-CARB counting HPM group
HPM (high protein meal), contained 36 g protein,17 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes.
Other: Calculation of insulin dosages for different meals
Calculation of insulin dosages For CARB counting meals using insulin-carbohydrate ratio for dosing mealtime boluses. For fat protein counting meal ICR and additionally fat-protein unit were used for dosing of mealtime boluses.
Experimental: Insulin dose-CARB counting HPFM group
HPFM (high protein-high fat meal), contained 36 g protein,30 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes.
Other: Calculation of insulin dosages for different meals
Calculation of insulin dosages For CARB counting meals using insulin-carbohydrate ratio for dosing mealtime boluses. For fat protein counting meal ICR and additionally fat-protein unit were used for dosing of mealtime boluses.
Experimental: Insulin dose-CARB+FPU counting-HPFM
HPFM (high protein-high fat meal), contained 36 g protein,30 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting plus fat-protein counting (insulin-to-carbohydrate ratio-ICR and fat-protein unit-FPU).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes.
Other: Calculation of insulin dosages for different meals
Calculation of insulin dosages For CARB counting meals using insulin-carbohydrate ratio for dosing mealtime boluses. For fat protein counting meal ICR and additionally fat-protein unit were used for dosing of mealtime boluses.
Active Comparator: Insulin dose-CARB counting SM group
SM (standart meal), contained 24 g protein,17 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR and fat-protein unit-FPU).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes.
Other: Calculation of insulin dosages for different meals
Calculation of insulin dosages For CARB counting meals using insulin-carbohydrate ratio for dosing mealtime boluses. For fat protein counting meal ICR and additionally fat-protein unit were used for dosing of mealtime boluses.

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
Change Postprandial Glucose Concentrations
Time Frame: 0-240 minutes
Change from baseline capillary blood glucose values at 240 min after control and test meals consumption.
0-240 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postprandial insulin need
Time Frame: [Time Frame: 0-240 minutes]
Insulin dosage was calculated by FPU (is defined as 100 calories of fat and protein) for HFPM-b meal.
[Time Frame: 0-240 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.
TC Erciyes University

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.
Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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 10, 2013

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.
February 20, 2014

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.
February 20, 2014

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 26, 2017

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.
November 2, 2017

First Posted (Actual)

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.
November 7, 2017

Study Record Updates

Last Update Posted (Actual)

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.
November 7, 2017

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.
November 2, 2017

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, 2017

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.
  • 2013/173
  • KEPAN (Other Grant/Funding Number: Turkish Clinical Enteral Parenteral Nutrition Society)
  • ESPEN Travel Grant (36 th) (Other Identifier: The European Society for Clinical Nutrition and Metabolism)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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