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

NCT04651205 | Suspended

• 1 other identifier: 200180160
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet, Carbohydrate-restricted

Keywords

glucose; low-carbohydrate; magnesium; thiamine; supplement

Outcome Measures

Primary Outcomes (6)

• 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

  changes from baseline and after supplementation

  8 weeks

Secondary Outcomes (9)

• 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

Study Arms (3)

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).

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).

Dietary Supplement: vitamin B1 and magnesium supplements

Interventions

vitamin B1 and magnesium supplements DIETARY_SUPPLEMENT

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

B1-Mg early start; Mg-B1 early start

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

University of Glasgow

Glasgow, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31006978 BACKGROUND

MeSH Terms

Interventions

Thiamine

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Chaitong Churuangsuk, MD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 3, 2020
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)