NCT03672513

Brief Summary

This is a 8-week, double-blinded, placebo-controlled, randomized intervention trial to investigate the effects of Mg and Zn supplementation on antioxidant status and bone hormonal parameters. Participants were randomly assigned to one of three treatment groups: Placebo group (PbG: 25 women); Magnesium Group - 500 mg/day of Mg (MgG: 27 women); Zinc Group - 50 mg/day of Zn (ZnG: 26 women).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

September 8, 2018

Last Update Submit

September 13, 2018

Conditions

MenopauseNutritional InterventionBone Diseases

Keywords

MenopuaseZincMagnesiumAntioxidantBone lossNutritional intervention

Outcome Measures

Primary Outcomes (2)

  • Antioxidant status

    Total antioxidant capacity (TAC) determination in plasma samples was carried out evaluating the reduction power of Cu2+ from the action of antioxidants present in samples (TAC kit, Jaica, Shizuoka, Japan). Values were expressed in umol/L.

    2 months

  • Oxidative stress

    Glutathione peroxidase (GPx) in mU/mL and Superoxide dismutase (SOD) in U/mL. GPx activity was determined by using the Bioxytech GPx-340™ kit (OxisResearch™), an indirect colorimetric assay of the activity of c-GPx \[28\]. SOD activity was determined by using the Randox Ransod kit (RANDOX Laboratories Ltd., United Kingdom).

    2 months

Secondary Outcomes (6)

  • Anthropometric assessment - Height

    2 months

  • Anthropometric assessment - Waist circumference

    2 months

  • Anthropometric assessment - Body composition by bioelectrical impedance

    2 months

  • Intake assessment

    2 months

  • Biochemical parameters - Clinical-nutritional parameters

    2 months

  • +1 more secondary outcomes

Study Arms (3)

Placebo Supplemented Group

PLACEBO COMPARATOR

Placebo control

Dietary Supplement: Placebo Comparator

Magnesium Supplemented Group

EXPERIMENTAL

Magnesium Group

Dietary Supplement: Magnesium supplement

Zinc Supplemented Group

EXPERIMENTAL

Zinc Group

Dietary Supplement: Zinc Supplement

Interventions

Placebo ComparatorDIETARY_SUPPLEMENT

Oral administration of 1 daily capsule containing lactose

Placebo Supplemented Group
Zinc SupplementDIETARY_SUPPLEMENT

Oral administration of 1 daily capsule containing 50 mg/day of Zn

Zinc Supplemented Group
Magnesium supplementDIETARY_SUPPLEMENT

Oral administration of 1 daily capsule containing 500 mg/day of Magnesium

Magnesium Supplemented Group

Eligibility Criteria

Age44 Years - 76 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale, Adult
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to present postmenopausal status (with at least 12 months of amenorrhea)
  • to present low status in Mg and/or Zn obtained in a previous biochemical assessment
  • not present any pathology that could affect their nutritional status
  • not to be subjected to hormone replacement therapy (HRT)
  • not to demonstrate lactose intolerance

You may not qualify if:

  • acute or terminal illness
  • unwillingness to either complete the study requirements or to be randomised into control or experimental group
  • to be smoker
  • to be on a medication regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Granada

Granada, 18071, Spain

Location

Related Publications (1)

  • Vazquez-Lorente H, Molina-Lopez J, Herrera-Quintana L, Gamarra-Morales Y, Quintero-Osso B, Lopez-Gonzalez B, Planells E. Erythrocyte Zn concentration and antioxidant response after supplementation with Zn in a postmenopausal population. A double-blind randomized trial. Exp Gerontol. 2022 Jun 1;162:111766. doi: 10.1016/j.exger.2022.111766. Epub 2022 Mar 9.

    PMID: 35278643DERIVED

MeSH Terms

Conditions

Bone DiseasesBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Elena Planells, PhD

    Universidad de Granada

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Professor

Study Record Dates

First Submitted

September 8, 2018

First Posted

September 14, 2018

Study Start

September 8, 2016

Primary Completion

November 1, 2017

Study Completion

September 8, 2018

Last Updated

September 14, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)