NCT03632590

Brief Summary

This four-arm randomized controlled trial was designed to study the effects of magnesium supplements (total daily dose: 450 mg elemental magnesium) on vascular stiffness in healthy overweight and slightly obese men and women. In addition, the effects of magnesium supplements on blood pressure and gut microbiota will be evaluated. Three groups will receive magnesium supplements (magnesium oxide, magnesium citrate or magnesium sulphate) and one group will receive a placebo.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

1.8 years

First QC Date

August 6, 2018

Last Update Submit

August 13, 2018

Conditions

Vascular StiffnessBlood Pressure

Keywords

MagnesiumSupplements

Outcome Measures

Primary Outcomes (1)

  • Change in vascular stiffness

    Measured from carotid-femoral pulse wave velocity (PWV). For this assessment, a SphygmoCor will be used (SphygmoCor v9, AtCor Medical).

    Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)

Secondary Outcomes (2)

  • Change in blood pressure

    Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)

  • Change in gut microbiota

    Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)

Study Arms (4)

Magnesium Citrate

EXPERIMENTAL

450 mg of Magnesium Citrate per day

Dietary Supplement: Magnesium Citrate

Magnesium Sulfate

EXPERIMENTAL

450 mg of Magnesium Sulfate per day

Dietary Supplement: Magnesium Sulfate

Magnesium Oxide

EXPERIMENTAL

450 mg of Magnesium Oxide per day

Dietary Supplement: Magnesium Oxide

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Magnesium CitrateDIETARY_SUPPLEMENT

450 mg of Magnesium Citrate per day (6 capsules per day) for 24 weeks

Magnesium Citrate
Magnesium SulfateDIETARY_SUPPLEMENT

450 mg of Magnesium Sulfate per day (6 capsules per day) for 24 weeks

Magnesium Sulfate
Magnesium OxideDIETARY_SUPPLEMENT

450 mg of Magnesium Oxide per day (6 capsules per day) for 24 weeks

Magnesium Oxide
PlaceboDRUG

The placebo capsules will contain starch (Amylum solani) for 24 weeks

Placebo

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 45-70 years
  • Women postmenopausal: two or more years after last menstruation
  • BMI between 25-35 kg/m2 (overweight and slightly obese)
  • Plasma glucose \< 7.0 mmol/L
  • Serum total cholesterol \< 8.0 mmol/L (further testing is recommended for excessive hyperlipidemia (serum total cholesterol ≥ 8.0 mmol/L) according to the Standard for cardiovascular risk management of the Dutch general practitioners community (NHG))
  • Serum triacylglycerol \< 4.5 mmol/L (Friedewald formula)
  • No current smoker
  • No diabetic patients
  • No familial hypercholesterolemia
  • No abuse of drugs
  • Less than 21 alcoholic consumptions per week
  • Stable body weight (weight gain or loss \<3 kg in the past three months)
  • No use of proton pump inhibitors
  • No use of magnesium supplements
  • No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
  • +4 more criteria

You may not qualify if:

  • High habitual dietary magnesium intake (defined as urinary magnesium excretion of 7.0 or 5.9 mmol/24-h or more for men and women, respectively)
  • Plasma glucose ≥ 7.0 mmol/L
  • Serum total cholesterol ≥ 8.0 mmol/L
  • Serum triacylglycerol ≥ 4.5 mmol/L
  • Current smoker, or smoking cessation \<12 months
  • Diabetic patients
  • Familial hypercholesterolemia
  • Abuse of drugs
  • More than 21 alcoholic consumptions per week
  • Unstable body weight (weight gain or loss \> 3 kg in the past three months)
  • Use of proton pump inhibitors
  • Use of magnesium supplements
  • Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
  • Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebro vascular accident
  • Not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Related Publications (2)

  • Schutten JC, Joris PJ, Groendijk I, Eelderink C, Groothof D, van der Veen Y, Westerhuis R, Goorman F, Danel RM, de Borst MH, Bakker SJL. Effects of Magnesium Citrate, Magnesium Oxide, and Magnesium Sulfate Supplementation on Arterial Stiffness: A Randomized, Double-Blind, Placebo-Controlled Intervention Trial. J Am Heart Assoc. 2022 Mar 15;11(6):e021783. doi: 10.1161/JAHA.121.021783. Epub 2022 Mar 5.

    PMID: 35253448DERIVED

  • Schutten JC, Joris PJ, Mensink RP, Danel RM, Goorman F, Heiner-Fokkema MR, Weersma RK, Keyzer CA, de Borst MH, Bakker SJL. Effects of magnesium citrate, magnesium oxide and magnesium sulfate supplementation on arterial stiffness in healthy overweight individuals: a study protocol for a randomized controlled trial. Trials. 2019 May 28;20(1):295. doi: 10.1186/s13063-019-3414-4.

    PMID: 31138315DERIVED

MeSH Terms

Interventions

magnesium citrateMagnesium SulfateMagnesium Oxide

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsOxidesOxygen Compounds

Study Officials

  • Stephan JL Bakker, MD-PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joëlle C Schutten, MSc

CONTACT

+31 50 3612679j.c.schutten@umcg.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 15, 2018

Study Start

March 27, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

NL(1)