Clinical trial NCT03672513: Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause
Official title: Short-term Supplementation, Bone Turnover and Antioxidant Status in Postmenopausal Stage: A Placebo Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Nutritional Intervention
Bone Diseases
Keywords: Menopuase
Zinc
Magnesium
Antioxidant
Bone loss
Nutritional intervention
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 78
Sex: FEMALE
Minimum age (years): 44
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Antioxidant status
timeFrame: 2 months
measure: Oxidative stress
timeFrame: 2 months
Secondary outcomes:
measure: Anthropometric assessment - Height
timeFrame: 2 months
measure: Anthropometric assessment - Waist circumference
timeFrame: 2 months
measure: Anthropometric assessment - Body composition by bioelectrical impedance
timeFrame: 2 months
measure: Intake assessment
timeFrame: 2 months
measure: Biochemical parameters - Clinical-nutritional parameters
timeFrame: 2 months
measure: Hormonal parameters
timeFrame: 2 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Universidad de Granada
Study officials:
affiliation: Universidad de Granada
name: Elena Planells, PhD
role: STUDY_DIRECTOR
References:
citation: 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.