Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause

NCT ID: NCT03672513

Last Updated: 2018-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-08

Study Completion Date

2018-09-08

Brief Summary

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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).

Detailed Description

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Seventy-eight healthy postmenopausal volunteers aged between 44 and 76 were recruited once had been informed about the protocol. 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).

Conditions

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Menopause Nutritional Intervention Bone Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Placebo Supplemented Group

Placebo control

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DIETARY_SUPPLEMENT

Oral administration of 1 daily capsule containing lactose

Magnesium Supplemented Group

Magnesium Group

Group Type EXPERIMENTAL

Magnesium supplement

Intervention Type DIETARY_SUPPLEMENT

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

Zinc Supplemented Group

Zinc Group

Group Type EXPERIMENTAL

Zinc Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Placebo Comparator

Oral administration of 1 daily capsule containing lactose

Intervention Type DIETARY_SUPPLEMENT

Zinc Supplement

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

Intervention Type DIETARY_SUPPLEMENT

Magnesium supplement

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

44 Years

Maximum Eligible Age

76 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Elena Planells del Pozo

University Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elena Planells, PhD

Role: STUDY_DIRECTOR

Universidad de Granada

Locations

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Universidad de Granada

Granada, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 35278643 (View on PubMed)

Other Identifiers

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FA COST Action TD1304

Identifier Type: -

Identifier Source: org_study_id

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