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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03672513
Other study ID # FA COST Action TD1304
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 8, 2016
Est. completion date September 8, 2018

Study information

Verified date September 2018
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date September 8, 2018
Est. primary completion date November 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 44 Years to 76 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Placebo Comparator
Oral administration of 1 daily capsule containing lactose
Zinc Supplement
Oral administration of 1 daily capsule containing 50 mg/day of Zn
Magnesium supplement
Oral administration of 1 daily capsule containing 500 mg/day of Magnesium

Locations

Country Name City State
Spain Universidad de Granada Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Anthropometric assessment - Height Values were expressed in centimeters. 2 months
Secondary Anthropometric assessment - Waist circumference Values were expressed in centimeters. 2 months
Secondary 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). 2 months
Secondary 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. 2 months
Secondary 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). 2 months
Secondary 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).
2 months
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