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B1 and Magnesium Supplements on Glucose Metabolism in Low-carb Dieters

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04651205
Acronym
B-Mag
Enrollment
18
Registered
2020-12-03
Start date
2021-10-31
Completion date
2022-10-31
Last updated
2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet, Carbohydrate-restricted

Keywords

glucose, low-carbohydrate, magnesium, thiamine, supplement

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.

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 Mg/B1 insufficiency, with negative impact on glucose metabolism. Objective 1. To investigate potential efficacy of Mg/B1 supplementation on glucose metabolism (mechanistic efficacy/proof of concept) in adults already voluntarily following LCHF 2. To investigate effect of Mg/B1 supplementation on Mg/B1 status in adults already voluntarily following LCHF, who are at risk of Mg/B1 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 efficacy/proof 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 intervention/untreated period

Interventions

DIETARY_SUPPLEMENTvitamin B1 and magnesium supplements

vitamin B1 - 100 mg/day magnesium - 400 mg/day

Sponsors

University of Glasgow
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. aged 18 years and older 2. have been following LCHF diets for at least 2 months 3. carbohydrate intake is less than 130 g/day or less than 26% of energy intake 4. have stable body weight (weight change ≤ 2 kg within two months period) 5. no diagnosed or suspected eating disorder.

Exclusion criteria

1. currently taking Mg and B1 supplements within the last 3 months 2. underweight defined by BMI below 18.5 kg/m2 3. have been diagnosed with T1DM or other types of diabetes apart from T2DM. 4. if potential participants have been diagnosed with T2DM, they will be excluded if they are on anti-diabetic drugs and/or insulin (see 7.) or if they are currently following a complete diet for weight loss (e.g. meal replacement, Slimfast, etc.) 5. currently taking anti-diabetic drugs (e.g. metformin, sulfonylurea, GLP-1 agonist, DPP4-inhibitor, SGLT-2 inhibitor, etc) nor insulin use 6. currently taking medications that interact with Mg supplement 7. currently taking medications that may affect glucose metabolism such as steroids, hormonal therapy (e.g. hormone replacement therapy in postmenopausal), antipsychotics. 8. pregnant and lactating women. 9. have gastrointestinal tract diseases e.g. Inflammatory bowel diseases, irritable bowel syndrome, coeliac disease, including other diseases that involve malabsorption. 10. have kidney disease or impair renal function 11. have auto-immune/connective tissue diseases, malignancy. 12. currently dieting or losing 5% of body weight or more during the last 6 months (or planning to do so in the following year). 13. currently participating in other intervention studies.

Design outcomes

Primary

MeasureTime frameDescription
fasting plasma glucose8 weekschanges from baseline and after supplementation
fasting insulin8 weekschanges from baseline and after supplementation
homeostatic model assessment of insulin resistance (HOMA-IR)8 weekschanges from baseline and after supplementation
incremental area under the curve (iAUC) of glucose and insulin after 75 g oral glucose tolerance test8 weekschanges from baseline and after supplementation
magnesium status8 weekschanges from baseline and after supplementation
vitamin B1 status8 weekschanges from baseline and after supplementation

Secondary

MeasureTime frameDescription
plasma fructosamine8 weekschanges from baseline and after supplementation
lipid profile: plasma Triglyceride, Total cholesterol, LDL-cholesterol, HDL-cholesterol8 weekschanges from baseline and after supplementation
dermal glycation by skin fluorescence8 weekschanges from baseline and after supplementation
HbA1c8 weekschanges from baseline and after supplementation
plasma hs-CRP8 weekschanges from baseline and after supplementation
plasma IL-68 weekschanges from baseline and after supplementation
sRAGE8 weekschanges from baseline and after supplementation
Urine 8-isoprostane8 weeks, MDA, glycation markers (fructosamine and HbA1c, dermal glycation by skin fluorescence)
plasma 8-isoprostane8 weekschanges from baseline and after supplementation

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026