Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04651205
Status:
SUSPENDED
Last Update Posted:
2021-04-30
First Post:
2020-11-24
Brief Title:
B1 and Magnesium Supplements on Glucose Metabolism in Low-carb Dieters
Sponsor:
University of Glasgow
Organization:
University of Glasgow
Study Overview
Official Title:
Effects of Vitamin B1 and Magnesium Supplements on Glucose Metabolism in Adults Voluntarily Following Reduced-carbohydrate Diets a Proof of Concept Intervention Study
Status:
SUSPENDED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
B-Mag
Brief Summary:
Magnesium Mg and thiamine vitamin B1 are micronutrients involved in the regulation of blood sugar level Avoidance of wholegrains or fruits and starchy vegetables could impact on Mg and vitamin B1 intakes and status Although supplementation can be recommended alongside low-carbohydrate high fat diets LCHF diets its benefits have never been studied before
This study aims to test the effect of Mg and vitamin B1 supplements on glucose metabolism in people following any LCHF diet
This study aims to test the effect of Mg and vitamin B1 supplements on glucose metabolism in people following any LCHF diet
Detailed Description:
It is clear that Mg involves in both type 2 diabetes T2D prevention and management and following LCHF diets avoidance of wholegrains fruits and starchy vegetables could have a negative impact on Mg and B1 intakes and status A systematic review of LCHF diets and micronutrients confirmed that Mg and B1 intakes were reduced by 50 and 70 following LCHF diets compared to baseline normal carbohydrate diets and could be as low as 40 and 75 of recommended intakes for Mg and B1 respectively Although supplementation can be recommended alongside LCHF diets not all LCHF dieters take supplements and their benefits during LCHF diets have never been studied before
Rationale We hypothesise that people who have been following LCHF diets without taking supplement are potentially at risk of MgB1 insufficiency with negative impact on glucose metabolism
Objective
1 To investigate potential efficacy of MgB1 supplementation on glucose metabolism mechanistic efficacyproof of concept in adults already voluntarily following LCHF
2 To investigate effect of MgB1 supplementation on MgB1 status in adults already voluntarily following LCHF who are at risk of MgB1 inadequacy
3 To test capabilities of measures procedures recruitment criteria and operational strategies that are under consideration for use in a subsequent larger study
4 To identify barriers to successful study completion
5 To evaluate acceptability of methods and instruments to participants
Study design This is a mechanistic efficacyproof of concept intervention study with a use of a randomised-start design All participants will be assigned to the same intervention but at different times
There are 3 groups of the study - 2 interventions and 1 control group
1 400 mg of Mg per day for 4 weeks then add on 100 mg of B1 per day for another 4 weeks a total duration of 8 weeks MB
2 100 mg of B1 per day for 4 weeks then add on 400 mg of Mg per day for another 4 weeks a total duration of 8 weeks BM
3 Untreated Participants with delayed entry untreated for 8 weeks Con
Assessment Baseline 4 weeks and 8 weeks after interventionuntreated period
Rationale We hypothesise that people who have been following LCHF diets without taking supplement are potentially at risk of MgB1 insufficiency with negative impact on glucose metabolism
Objective
1 To investigate potential efficacy of MgB1 supplementation on glucose metabolism mechanistic efficacyproof of concept in adults already voluntarily following LCHF
2 To investigate effect of MgB1 supplementation on MgB1 status in adults already voluntarily following LCHF who are at risk of MgB1 inadequacy
3 To test capabilities of measures procedures recruitment criteria and operational strategies that are under consideration for use in a subsequent larger study
4 To identify barriers to successful study completion
5 To evaluate acceptability of methods and instruments to participants
Study design This is a mechanistic efficacyproof of concept intervention study with a use of a randomised-start design All participants will be assigned to the same intervention but at different times
There are 3 groups of the study - 2 interventions and 1 control group
1 400 mg of Mg per day for 4 weeks then add on 100 mg of B1 per day for another 4 weeks a total duration of 8 weeks MB
2 100 mg of B1 per day for 4 weeks then add on 400 mg of Mg per day for another 4 weeks a total duration of 8 weeks BM
3 Untreated Participants with delayed entry untreated for 8 weeks Con
Assessment Baseline 4 weeks and 8 weeks after interventionuntreated period
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