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

University of Granada (UGR)

Status: Completed

Conditions: Menopause; Nutritional Intervention; Bone Diseases

Treatments: Dietary Supplement: Magnesium supplement; Dietary Supplement: Zinc Supplement; Dietary Supplement: Placebo Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT03672513

FA COST Action TD1304

Details and patient eligibility

About

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).

Full 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).

Enrollment: 78 patients

Sex: Female

Ages: 44 to 76 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 3 patient groups, including a placebo group

Placebo Supplemented Group

Placebo Comparator group

Description:

Placebo control

Treatment:

Dietary Supplement: Placebo Comparator

Magnesium Supplemented Group

Experimental group

Description:

Magnesium Group

Treatment:

Dietary Supplement: Magnesium supplement

Zinc Supplemented Group

Experimental group

Description:

Zinc Group

Treatment:

Dietary Supplement: Zinc Supplement