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

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).

Study Overview

• Status: Completed
• Conditions: Bone Diseases; Menopause; Nutritional Intervention
• Intervention / Treatment: Dietary supplement: Placebo Comparator; Dietary supplement: Magnesium supplement; Dietary supplement: Zinc Supplement

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).

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18071
    • Universidad de Granada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 44 years to 76 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Supplemented Group; Placebo control	Dietary supplement: Placebo Comparator; Oral administration of 1 daily capsule containing lactose
EXPERIMENTAL: Magnesium Supplemented Group; Magnesium Group	Dietary supplement: Magnesium supplement; Oral administration of 1 daily capsule containing 500 mg/day of Magnesium
EXPERIMENTAL: Zinc Supplemented Group; Zinc Group	Dietary supplement: Zinc Supplement; Oral administration of 1 daily capsule containing 50 mg/day of Zn

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric assessment - Height	Values were expressed in centimeters.	2 months
Anthropometric assessment - Waist circumference	Values were expressed in centimeters.	2 months
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
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
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
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

Collaborators and Investigators

• Sponsor: Universidad de Granada

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 8, 2016
• Primary Completion (ACTUAL): November 1, 2017
• Study Completion (ACTUAL): September 8, 2018

Study Registration Dates

• First Submitted: September 8, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (ACTUAL): September 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Magnesium; Zinc; Antioxidant; Bone loss; Nutritional intervention; Menopuase
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases
• Other Study ID Numbers: FA COST Action TD1304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No