Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04550468
Status:
COMPLETED
Last Update Posted:
2022-09-23
First Post:
2020-07-15
Brief Title:
Low-carbohydrate Versus Low-fat Breakfast in Type 2 Diabetes
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Impact of a Low-carbohydrate Versus Low-fat Breakfast on Blood Glucose Control in Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prevalence of type 2 diabetes T2D is increasing worldwide with 380 M currently suffering from this chronic debilitating disease T2D is characterized by high blood glucose levels in the mornings and after meals The largest hyperglycemic spike often occurs after breakfast Targeting this meal may be a simple feasible strategy to improve glycemic control and reduce risk for diabetes complications It is hypothesized that consuming a low carbohydrate high fat LCHF breakfast for 3 months when compared to a standard low-fat breakfast will improve blood glucose control increase satiety and improve body composition in people with T2D This information will test whether the simple dietary strategy of limiting carbohydrates at breakfast could help in managing T2D
Detailed Description:
A 3-month parallel-group randomized controlled trial will be conducted Eligible participants will be randomized to either the Low-carb High-fat breakfast LCHF n41 or a low-fat standard care control breakfast CTL n41 to be consumed daily for a period of 3 months
Due to COVID-19 pandemic this study was adapted to be conducted remotely through videotelephone conference meetings between participants and study staff along with mailing of study materials before and after the intervention for remote data collection
Each group will be provided with a menu of 8 LCHF breakfasts or 8 CTL breakfasts from which to choose each morning Breakfast options designed by a registered dietitian will be controlled in macronutrient content and calories 400-500 kcal but allow for personal preference and autonomy to promote adherence
Due to COVID-19 pandemic this study was adapted to be conducted remotely through videotelephone conference meetings between participants and study staff along with mailing of study materials before and after the intervention for remote data collection
Each group will be provided with a menu of 8 LCHF breakfasts or 8 CTL breakfasts from which to choose each morning Breakfast options designed by a registered dietitian will be controlled in macronutrient content and calories 400-500 kcal but allow for personal preference and autonomy to promote adherence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None