Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 11:46 PM
Study NCT ID:
NCT04550468
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2020-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low-carbohydrate Versus Low-fat Breakfast in Type 2 Diabetes
Sponsor:
University of British Columbia
Organization:
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:
2025-02
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, n=41) or a low-fat "standard care" control breakfast (CTL, n=41), to be consumed daily for a period of 3 months.
Due to COVID-19 pandemic, this study was adapted to be conducted remotely through video/telephone 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 video/telephone 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:
False
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?: