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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672513
• Other study ID #: FA COST Action TD1304
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bone Diseases
• Menopause
• Nutritional Intervention

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