Does Protein and Fat Content of Meal Increase Glucose Concentrations

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: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Calculation of insulin dosages for different meals

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial insulin need	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

• Sponsor: TC Erciyes University
• Collaborators: Hacettepe University

Publications and helpful links

General Publications

• Kaya N, Kurtoglu S, Gokmen Ozel H. Does meal-time insulin dosing based on fat-protein counting give positive results in postprandial glycaemic profile after a high protein-fat meal in adolescents with type 1 diabetes: a randomised controlled trial. J Hum Nutr Diet. 2020 Jun;33(3):396-403. doi: 10.1111/jhn.12711. Epub 2019 Oct 24.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2013
• Primary Completion (Actual): February 20, 2014
• Study Completion (Actual): February 20, 2014

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Fat-protein counting; Postprandial glucose level
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID 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