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

Sponsor

Universidad de Granada (Other)

Overall Status

Completed

CT.gov ID

NCT03672513

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Menopause Nutritional Intervention Bone Diseases	Dietary Supplement: Placebo Comparator Dietary Supplement: Zinc Supplement Dietary Supplement: Magnesium supplement	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 8, 2016

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Sep 8, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Antioxidant status [2 months]
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.
Oxidative stress [2 months]
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).

Secondary Outcome Measures

Anthropometric assessment - Height [2 months]
Values were expressed in centimeters.
Anthropometric assessment - Waist circumference [2 months]
Values were expressed in centimeters.
Anthropometric assessment - Body composition by bioelectrical impedance [2 months]
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).
Intake assessment [2 months]
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.
Biochemical parameters - Clinical-nutritional parameters [2 months]
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).
Hormonal parameters [2 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

44 Years to 76 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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