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Open Access 01-12-2023 | Nutrition | Study protocol

Protocol for a randomized controlled trial comparing a very low-carbohydrate diet or moderate-carbohydrate plate-method diet for type 2 diabetes: the LEGEND (Lifestyle Education about Nutrition for Diabetes) trial

Authors: Laura R. Saslow, Adriana Eslamian, Patricia Moran, Wendy Hartogensis, Ashley E. Mason, Sarah Kim, Douglas C. Bauer, Dina Hafez Griauzde, Veronica Goldman, Vivian Liu, Pam Stephens, Kate Raymond, George Yeung, Cindy Leung, Frederick M. Hecht

Published in: Trials | Issue 1/2023

Abstract

Background

Optimal carbohydrate intake is an important and controversial area in the nutritional management of type 2 diabetes. Some evidence indicates that reducing overall carbohydrate intake with a low- or very low-carbohydrate eating plan can improve glycemic control compared to following eating plans that involve greater carbohydrate intake. However, critical knowledge gaps currently prevent clear recommendations about carbohydrate intake levels.

Methods

The LEGEND (Lifestyle Education about Nutrition for Diabetes) Trial aims to compare a very low-carbohydrate diet to a moderate-carbohydrate plate-method diet for glycemic control in adults with type 2 diabetes. This two-site trial plans to recruit 180 adults with type 2 diabetes. We will randomize participants to either a 20-session group-based diet and lifestyle intervention that teaches either a very low-carbohydrate diet or a moderate-carbohydrate plate-method diet. We will assess participants at study entry and 4 and 12 months later. The primary outcome is HbA1c, and secondary outcomes include inflammation (high sensitivity C-reactive protein), body weight, changes in diabetes medications, lipids (small particle LDL, HDL, triglycerides), skeletal metabolism (bone mineral density from dual-energy x-ray absorptiometry and bone turnover markers serum procollagen type I N propeptide and serum C-terminal telopeptide of type I collagen), and body composition (percent body fat, percent lean body mass).

Discussion

The LEGEND trial is a randomized controlled trial to assess optimal carbohydrate intake in type 2 diabetes by evaluating the effects of a very low-carbohydrate diet vs. a moderate-carbohydrate plate-method diet over a year-long period. The research addresses important gaps in the evidence base for the nutritional management of type 2 diabetes by providing data on potential benefits and adverse effects of different levels of carbohydrate intake.

Trial registration

ClinicalTrials.gov NCT05237128. Registered on February 11, 2022

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Title: Protocol for a randomized controlled trial comparing a very low-carbohydrate diet or moderate-carbohydrate plate-method diet for type 2 diabetes: the LEGEND (Lifestyle Education about Nutrition for Diabetes) trial
Authors: Laura R. Saslow
Adriana Eslamian
Patricia Moran
Wendy Hartogensis
Ashley E. Mason
Sarah Kim
Douglas C. Bauer
Dina Hafez Griauzde
Veronica Goldman
Vivian Liu
Pam Stephens
Kate Raymond
George Yeung
Cindy Leung
Frederick M. Hecht
Publication date: 01-12-2023
Publisher: BioMed Central
Keywords: Nutrition
Type 2 Diabetes
Published in: Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-023-07512-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Protocol for a randomized controlled trial comparing a very low-carbohydrate diet or moderate-carbohydrate plate-method diet for type 2 diabetes: the LEGEND (Lifestyle Education about Nutrition for Diabetes) trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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