B1 and Magnesium Supplements on Glucose Metabolism in Low-carb Dieters (B-Mag)

April 27, 2021 updated by: Chaitong Churuangsuk, MD, University of Glasgow

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Untreated
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).
Experimental: Mg-B1 early start
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).
Dietary supplement: vitamin B1 and magnesium supplements
vitamin B1 - 100 mg/day magnesium - 400 mg/day
Experimental: B1-Mg early start
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).
Dietary supplement: vitamin B1 and magnesium supplements
vitamin B1 - 100 mg/day magnesium - 400 mg/day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
fasting plasma glucose
Time Frame: 8 weeks
changes from baseline and after supplementation
8 weeks
fasting insulin
Time Frame: 8 weeks
changes from baseline and after supplementation
8 weeks
homeostatic model assessment of insulin resistance (HOMA-IR)
Time Frame: 8 weeks
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
Time Frame: 8 weeks
changes from baseline and after supplementation
8 weeks
magnesium status
Time Frame: 8 weeks
changes from baseline and after supplementation
8 weeks
vitamin B1 status
Time Frame: 8 weeks
changes from baseline and after supplementation
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
lipid profile: plasma Triglyceride, Total cholesterol, LDL-cholesterol, HDL-cholesterol
Time Frame: 8 weeks
changes from baseline and after supplementation
8 weeks
plasma hs-CRP
Time Frame: 8 weeks
changes from baseline and after supplementation
8 weeks
plasma IL-6
Time Frame: 8 weeks
changes from baseline and after supplementation
8 weeks
sRAGE
Time Frame: 8 weeks
changes from baseline and after supplementation
8 weeks
Urine 8-isoprostane
Time Frame: 8 weeks
, MDA, glycation markers (fructosamine and HbA1c, dermal glycation by skin fluorescence)
8 weeks
plasma 8-isoprostane
Time Frame: 8 weeks
changes from baseline and after supplementation
8 weeks
plasma fructosamine
Time Frame: 8 weeks
changes from baseline and after supplementation
8 weeks
HbA1c
Time Frame: 8 weeks
changes from baseline and after supplementation
8 weeks
dermal glycation by skin fluorescence
Time Frame: 8 weeks
changes from baseline and after supplementation
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Glasgow

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chaitong Churuangsuk, MD, University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 200180160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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