Sponsor study identifier
interventional
18
1 country
1
Study Start
October 2021
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Primary Completion
October 2022
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Study Completion
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 24, 2020
Actual (reported)December 3, 2020
Actual (reported)October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
fasting plasma glucose
changes from baseline and after supplementation
8 weeks
fasting insulin
changes from baseline and after supplementation
8 weeks
homeostatic model assessment of insulin resistance (HOMA-IR)
changes from baseline and after supplementation
8 weeks
incremental area under the curve (iAUC) of glucose and insulin after 75 g oral glucose tolerance test
changes from baseline and after supplementation
8 weeks
magnesium status
changes from baseline and after supplementation
8 weeks
vitamin B1 status
lipid profile: plasma Triglyceride, Total cholesterol, LDL-cholesterol, HDL-cholesterol
8 weeks
plasma hs-CRP
8 weeks
plasma IL-6
8 weeks
sRAGE
8 weeks
Urine 8-isoprostane
8 weeks
This control group will be untreated for 8 weeks as to be a controlled group. Then all participants in the control group will be randomised again to either Mg-B1 or B1-Mg groups for another 8 weeks (delayed-start intervention).
Participants in the Mg-B1 are the 'early start' group where they will receive 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 (MgB1).
Participants in the B1-Mg are the 'early start' group where they will receive 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 (B1Mg).
vitamin B1 - 100 mg/day magnesium - 400 mg/day
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Glasgow
Glasgow, United Kingdom
Churuangsuk C, Griffiths D, Lean MEJ, Combet E. Impacts of carbohydrate-restricted diets on micronutrient intakes and status: A systematic review. Obes Rev. 2019 Aug;20(8):1132-1147. doi: 10.1111/obr.12857. Epub 2019 Apr 22.
Chaitong Churuangsuk, MD
University of Glasgow
First Submitted
November 24, 2020
First Posted
December 3, 2020
Study Start
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2022
changes from baseline and after supplementation
8 weeks
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 30, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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