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

Details

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
Author
Saslow, Laura R. 1   VIAFID ORCID Logo  ; Eslamian, Adriana 2 ; Moran, Patricia 2 ; Hartogensis, Wendy 2 ; Mason, Ashley E. 2 ; Kim, Sarah 2 ; Bauer, Douglas C. 2 ; Griauzde, Dina Hafez 1 ; Goldman, Veronica 2 ; Liu, Vivian 2 ; Stephens, Pam 1 ; Raymond, Kate 1 ; Yeung, George 2 ; Leung, Cindy 3 ; Hecht, Frederick M. 2 

1  University of Michigan, Ann Arbor, USA (GRID:grid.214458.e) (ISNI:0000000086837370) 
2  University of California, San Francisco, USA (GRID:grid.266102.1) (ISNI:0000 0001 2297 6811) 
3  Harvard University, Cambridge, USA (GRID:grid.38142.3c) (ISNI:000000041936754X) 
Pages
463
Publication year
2023
Publication date
Dec 2023
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-023-07512-9
ProQuest document ID
2840091765
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.