Effects of vitamin D and/or magnesium supplementation on mood, serum levels of BDNF, inflammatory biomarkers, and SIRT1 in obese women: a study protocol for a double-blind, randomized, placebo-controlled trial

Trials. 2020 Feb 26;21(1):225. doi: 10.1186/s13063-020-4122-9.

Abstract

Background: Emerging evidence has shown that vitamin D and magnesium have anti-inflammatory and anti-depressant effects. Dietary intake of magnesium is associated with reduced body mass index, waist circumference, body fat percentage, as well as inflammatory biomarkers and depressive symptoms. Vitamin D deficiency has been linked to inflammation, obesity, and depressive symptoms. This study will test the effects of vitamin D and magnesium co-supplementation on mood, serum level of brain-derived neurotrophic factor (BDNF), inflammation, and sirtuin 1 (SIRT1) in obese women.

Methods: We will conduct an 8-week, double-blind, randomized, placebo-controlled clinical trial, in a factorial design, to evaluate the individual effects of vitamin D and magnesium, and co-supplementation of them, on mood, serum level of BDNF, inflammation, and SIRT1 in 108 obese women.

Discussion: We hypothesize that vitamin D and magnesium co-supplementation may provide a new adjuvant therapy through modulation of BDNF, inflammation, and SIRT1 in obese women.

Trial registration: Iranian Registry of Clinical Trials, IRCT20090822002365N23. Registered on 16 August 2019.

Keywords: Brain-derived neurotrophic factor; Inflammatory biomarkers; Magnesium; Mood; Obese women; Sirtuin 1; Vitamin D.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adolescent
  • Adult
  • Affect*
  • Brain-Derived Neurotrophic Factor / blood*
  • C-Reactive Protein / analysis*
  • Dietary Supplements
  • Double-Blind Method
  • Female
  • Humans
  • Inflammation / prevention & control*
  • Magnesium / administration & dosage*
  • Middle Aged
  • Obesity / blood*
  • Obesity / psychology
  • Outcome Assessment, Health Care
  • Sirtuin 1 / blood*
  • Vitamin D / administration & dosage*
  • Young Adult

Substances

  • Brain-Derived Neurotrophic Factor
  • Vitamin D
  • BDNF protein, human
  • C-Reactive Protein
  • SIRT1 protein, human
  • Sirtuin 1
  • Magnesium