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MenopauseNCT03672513

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

A study testing Zinc Supplement and Magnesium supplement in people with Menopause and Nutritional Intervention, run by Universidad de Granada at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 44 to 76 years, women onlyHealthy volunteers can take part
Conditions the study is for
Menopause, Nutritional Intervention, Bone Diseases
What is being tested?
Zinc Supplement and Magnesium supplement
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
1 siteSpain
Study dates
8 Sep 2016to 8 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 44 to 76 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad de Granada

    Granada, 18071

Other trials in Spain

About this study

Official title: Short-term Supplementation, Bone Turnover and Antioxidant Status in Postmenopausal Stage: A Placebo Controlled Study.

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).

Read the detailed description

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).

Being tested
Placebo Comparator, Zinc Supplement, Magnesium supplement
Keywords
Menopuase, Zinc, Magnesium, Antioxidant, Bone loss, Nutritional intervention
Medical subject headings
Bone Diseases, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo ComparatorDietary supplement

    Oral administration of 1 daily capsule containing lactose

  • Zinc SupplementDietary supplement

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

  • Magnesium supplementDietary supplement

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

Study groups in NCT03672513
Study groupRoleWhat they receive
Placebo Supplemented GroupPlacebo comparatorPlacebo control
Receives: Dietary Supplement: Placebo Comparator
Magnesium Supplemented GroupExperimentalMagnesium Group
Receives: Dietary Supplement: Magnesium supplement
Zinc Supplemented GroupExperimentalZinc Group
Receives: Dietary Supplement: Zinc Supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 months

  2. 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).

    Measured: 2 months

Secondary outcomes (6)

  1. Anthropometric assessment - Height

    Values were expressed in centimeters.

    Measured: 2 months

  2. Anthropometric assessment - Waist circumference

    Values were expressed in centimeters.

    Measured: 2 months

  3. Anthropometric assessment - Body composition by bioelectrical impedance

    Body composition assessment was taken by multifrequency bioelectrical impedance (Tanita MC-980 Body Composition Analyzer MA Multifrequency Segmental, Barcelona, Spain). The analyzer complies with the applicable European standards (93/42EEC, 90/384EEC) for use in the medical industry. Participants were informed in advance of the required conditions prior to the measurement: no alcohol less than 24 hours before the measurement, no vigorous exercise less than 12 hours prior to the measurement, no food or drink less than 3 hours prior to the measurement, and no urination immediately before the measurement. All measurements were taken simultaneously during the morning in fasting conditions. The following measurements were taken: weight, body mass index (calculated as weight/height^2 and expressed kg/m2) and fat mass (expressed in kilograms and as the percentage of body fat), fat free mass (expressed in kilograms and as the percentage of fat free mass), muscle mass (expressed in kilograms).

    Measured: 2 months

  4. Intake assessment

    Dietary intake was performed at baseline and after two months of intervention. Nutritional assessment was quantitatively and qualitatively performed using a 72 hours' dietary record and food frequency questionnaire (FFQ). Data from food intakes were obtained in the course of individual interviews to request information from each participant about the types of foods and serving sizes. Dietary intake was compared with the daily recommended allowances (DRA). Insufficient intake levels were determined by comparing actual intakes of different nutrients with the recommended intake for each participant and were recorded as below 75% of the RDA. FFQ was used to set the information about the frequency consumption in each group of foods. FFQ was compared with the recommendations proposed by the Spanish Community Nutrition Society (SENC) and expressed as the percentage of participants below or above the recommended servings.

    Measured: 2 months

  5. Biochemical parameters - Clinical-nutritional parameters

    Biochemistry was performed after 12 hours of fasting first thing in the morning, by specialists puncturing the cubital vena cava (Venoject®). The following measurements were taken: Glucose (mg/dL), creatinine (mg/dL), urea (mg/dL), uric acid (mg/dL), triglycerides (mg/dL), total cholesterol (mg/dL), total proteins (g/dL), transferrin (mg/dL) and albumin (mg/dL).

    Measured: 2 months

  6. Hormonal parameters

    Hormonal parameters were performed after 12 hours of fasting first thing in the morning, by specialists puncturing the cubital vena cava (Venoject®) and determined by colorimetric enzymoimmunoassay techniques (ECLIA, Elecsys 2010 and Modular Analytics E170, Roche Diagnostics, Mannheim, Germany.

    The following measurements were taken: leptin (ng/mL), PTH (pg/mL) and Osteocalcin (pg/mL).

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start8 Sep 2016
  3. Primary completion1 Nov 2017
  4. Study completion8 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03672513
Sponsor's protocol ID
FA COST Action TD1304
Status last verified
Sep 2018
First submitted
8 Sep 2018
Last updated
14 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35278643

Questions about this trial

What is this clinical trial studying?

A study testing Zinc Supplement and Magnesium supplement in people with Menopause and Nutritional Intervention, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antioxidant status (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03672513, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.

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