Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study

Summary

The cornerstone in the initial treatment of type 2 diabetes (T2D) is lifestyle modification, involving-among other things-a healthy diet. However, scientific evidence regarding optimal nutrition therapy for patients with T2D is insufficient.

This clinical study will examine the effect of a carbohydrate-reduced high-protein (CRHP) diet compared to a conventional diabetes (CD) diet for 12 months on metabolic function and body weight in patients with T2D.

The hypothesis of the study is that the CRHP diet will improve metabolic control and the cardiovascular risk profile of patients with T2D to a greater extent than the CD diet. In particular, the expectation is that, compared with the CD diet, the CRHP diet will:

* Reduce diurnal and postprandial glycemia measured by continuous glucose monitoring (CGM) and thereby facilitate a significant reduction of glycated hemoglobin (HbA1c)
* Reduce body weight
* Reduce ectopic fat deposition in the liver and the pancreas
* Improve the blood lipid profile
* Reduce or not affect blood pressure with no adverse effect on heart rate variability
* Increase insulin sensitivity and secretion
* Decrease inflammatory markers in the blood
* Improve satiety
* Reduce or not affect the need for antidiabetic, antihypertensive and/or lipid-lowering medications

To reinforce the results and knowledge generated from the primary study, participants will be invited to partake in a 12-month follow-up period after the initial 12 months of intervention.

Conditions

• Diabetes Mellitus Type 2
• Overweight and Obesity

Interventions

OTHER

Carbohydrate-reduced high-protein (CRHP) Diet

Macronutrient intake of 30 percentage of energy from carbohydrate, 30 percentage of energy from protein and 40 percentage of energy from fat.

OTHER

Conventional diabetes (CD) Diet

Macronutrient intake of 50 percentage of energy from carbohydrate, 17 percentage of energy from protein and 33 percentage of energy from fat.

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• University of Aarhus

  collaborator OTHER

• The Danish Dairy Research Foundation, Denmark

  collaborator OTHER

• Arla Foods

  collaborator INDUSTRY

• The Købmand Niels Erik Munk Pedersen Foundation

  collaborator UNKNOWN

• Hvidovre University Hospital

  collaborator OTHER

• Bispebjerg Hospital

  lead OTHER

Principal Investigators

• Thure Krarup, MD, DMSc · Dept. of Endocrinology, Copenhagen University Hospital, Bispebjerg and Frederiksberg

• Luise H Kopp-Nilsson, MSc, RD · Dept. of Endocrinology, Copenhagen University Hospital, Bispebjerg and Frederiksberg

• Rasmus B Mainz Hansen, MD · Dept. of Endocrinology, Copenhagen University Hospital, Bispebjerg and Frederiksberg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-27

Primary Completion

2026-03-15

Completion

2026-04-30

Countries

• Denmark

Study Locations