Diet, Carbohydrate-restrictedB-MagNCT04651205
B1 and Magnesium Supplements on Glucose Metabolism in Low-carb Dieters
A study testing vitamin B1 and magnesium supplements in people with Diet, Carbohydrate-restricted, run by University of Glasgow at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Carbohydrate-restricted
- What is being tested?
- vitamin B1 and magnesium supplements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 years and older
- have been following LCHF diets for at least 2 months
- carbohydrate intake is less than 130 g/day or less than 26% of energy intake
- have stable body weight (weight change ≤ 2 kg within two months period)
- no diagnosed or suspected eating disorder.
Who cannot join
- currently taking Mg and B1 supplements within the last 3 months
- underweight defined by BMI below 18.5 kg/m2
- have been diagnosed with T1DM or other types of diabetes apart from T2DM.
- 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.)
- currently taking anti-diabetic drugs (e.g. metformin, sulfonylurea, GLP-1 agonist, DPP4-inhibitor, SGLT-2 inhibitor, etc) nor insulin use
- currently taking medications that interact with Mg supplement
Show all 13Show fewer
- currently taking medications that may affect glucose metabolism such as steroids, hormonal therapy (e.g. hormone replacement therapy in postmenopausal), antipsychotics.
- pregnant and lactating women.
- have gastrointestinal tract diseases e.g. Inflammatory bowel diseases, irritable bowel syndrome, coeliac disease, including other diseases that involve malabsorption.
- have kidney disease or impair renal function
- have auto-immune/connective tissue diseases, malignancy.
- currently dieting or losing 5% of body weight or more during the last 6 months (or planning to do so in the following year).
- currently participating in other intervention studies.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- To investigate potential efficacy of Mg/B1 supplementation on glucose metabolism (mechanistic efficacy/proof of concept) in adults already voluntarily following LCHF
- 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
- To test capabilities of measures, procedures, recruitment criteria, and operational strategies that are under consideration for use in a subsequent, larger, study.
- To identify barriers to successful study completion
- 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:
- 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).
- 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).
- Untreated: Participants with delayed entry (untreated) for 8 weeks (Con)
Assessment: Baseline, 4 weeks, and 8 weeks after intervention/untreated period
- Conditions
- Diet, Carbohydrate-restricted
- Being tested
- vitamin B1 and magnesium supplements
- Keywords
- glucose, low-carbohydrate, magnesium, thiamine, supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin B1 and magnesium supplementsDietary supplement
vitamin B1 - 100 mg/day magnesium - 400 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Untreated | No intervention | 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). |
| Mg-B1 early start | Experimental | 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). Receives: Dietary Supplement: vitamin B1 and magnesium supplements |
| B1-Mg early start | Experimental | 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). Receives: Dietary Supplement: vitamin B1 and magnesium supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting plasma glucose
changes from baseline and after supplementation
Measured: 8 weeks
fasting insulin
changes from baseline and after supplementation
Measured: 8 weeks
homeostatic model assessment of insulin resistance (HOMA-IR)
changes from baseline and after supplementation
Measured: 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
Measured: 8 weeks
magnesium status
changes from baseline and after supplementation
Measured: 8 weeks
vitamin B1 status
changes from baseline and after supplementation
Measured: 8 weeks
Secondary outcomes (9)
lipid profile: plasma Triglyceride, Total cholesterol, LDL-cholesterol, HDL-cholesterol
changes from baseline and after supplementation
Measured: 8 weeks
plasma hs-CRP
changes from baseline and after supplementation
Measured: 8 weeks
plasma IL-6
changes from baseline and after supplementation
Measured: 8 weeks
sRAGE
changes from baseline and after supplementation
Measured: 8 weeks
Urine 8-isoprostane
, MDA, glycation markers (fructosamine and HbA1c, dermal glycation by skin fluorescence)
Measured: 8 weeks
plasma 8-isoprostane
changes from baseline and after supplementation
Measured: 8 weeks
plasma fructosamine
changes from baseline and after supplementation
Measured: 8 weeks
HbA1c
changes from baseline and after supplementation
Measured: 8 weeks
dermal glycation by skin fluorescence
changes from baseline and after supplementation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet, Carbohydrate-restrictedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaitong Churuangsuk, MD, University of Glasgow
- Investigators
- Chaitong Churuangsuk, MD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651205
- Sponsor's protocol ID
- 200180160
- Acronym
- B-Mag
- Status last verified
- Apr 2021
- First submitted
- 24 Nov 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31006978
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04651205
- Acronym / sponsor ID
- B-Mag / 200180160
- Conditions
- Diet, Carbohydrate-restricted
- Keywords
- glucose, low-carbohydrate, magnesium, thiamine, supplement
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19 pandemic
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To investigate potential efficacy of Mg/B1 supplementation on glucose metabolism (mechanistic efficacy/proof of concept) in adults already voluntarily following LCHF
- 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
- To test capabilities of measures, procedures, recruitment criteria, and operational strategies that are under consideration for use in a subsequent, larger, study.
- To identify barriers to successful study completion
- 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:
- 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).
- 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).
- Untreated: Participants with delayed entry (untreated) for 8 weeks (Con)
Assessment: Baseline, 4 weeks, and 8 weeks after intervention/untreated period
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Untreated | No intervention | –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). |
| Mg-B1 early start | Experimental | Dietary Supplement: vitamin B1 and magnesium supplementsParticipants 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). |
| B1-Mg early start | Experimental | Dietary Supplement: vitamin B1 and magnesium supplementsParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18 years and older
- have been following LCHF diets for at least 2 months
- carbohydrate intake is less than 130 g/day or less than 26% of energy intake
- have stable body weight (weight change ≤ 2 kg within two months period)
- no diagnosed or suspected eating disorder.
Key exclusion criteria (13 listed)
- currently taking Mg and B1 supplements within the last 3 months
- underweight defined by BMI below 18.5 kg/m2
- have been diagnosed with T1DM or other types of diabetes apart from T2DM.
- 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.)
- currently taking anti-diabetic drugs (e.g. metformin, sulfonylurea, GLP-1 agonist, DPP4-inhibitor, SGLT-2 inhibitor, etc) nor insulin use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin B1 and magnesium supplementsvitamin B1 - 100 mg/day magnesium - 400 mg/day | Dietary supplement | B1-Mg early start, Mg-B1 early start |
Primary outcome
fasting plasma glucose
Time frame: 8 weeks
changes from baseline and after supplementation
fasting insulin
Time frame: 8 weeks
changes from baseline and after supplementation
homeostatic model assessment of insulin resistance (HOMA-IR)
Time frame: 8 weeks
changes from baseline and after supplementation
incremental area under the curve (iAUC) of glucose and insulin after 75 g oral glucose tolerance test
Time frame: 8 weeks
changes from baseline and after supplementation
magnesium status
Time frame: 8 weeks
changes from baseline and after supplementation
vitamin B1 status
Time frame: 8 weeks
changes from baseline and after supplementation
9 secondary outcomes
lipid profile: plasma Triglyceride, Total cholesterol, LDL-cholesterol, HDL-cholesterol
Time frame: 8 weeks
plasma hs-CRP
Time frame: 8 weeks
plasma IL-6
Time frame: 8 weeks
sRAGE
Time frame: 8 weeks
Urine 8-isoprostane
Time frame: 8 weeks
plasma 8-isoprostane
Time frame: 8 weeks
plasma fructosamine
Time frame: 8 weeks
HbA1c
Time frame: 8 weeks
dermal glycation by skin fluorescence
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Background: PubMed 31006978Churuangsuk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaitong Churuangsuk, MD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin B1 and magnesium supplements in people with Diet, Carbohydrate-restricted, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting plasma glucose (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04651205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.