Effects of Tryptophan and Magnesium-Enriched Mediterranean Diet in Women With Fibromyalgia

Overview

The main aim of study was to analyze the effects of tryptophan and magnesium-enriched Mediterranean diet on psychological variables (trait anxiety, self-image, mood state, eating disorders) and sleep effects in women with fibromyalgia. Our hypothesis, based on previous positive effects of tryptophan and magnesium supplementation by separate in this population, may improve psychological health and regulate sleep disruptions.

Full Title of Study: “Psychological and Sleep Effects of Tryptophan and Magnesium-Enriched Mediterranean Diet in Women With Fibromyalgia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 9, 2019

Interventions

  • Other: Mediterranean-diet enriched with a higher dose of tryptophan and magnesium
    • That gruop eaten at both breakfast and dinner from walnuts (3-5 units), as food with high values of tryptophan and magnesium
  • Other: Isocaloric diet
    • That group eaten isocaloric diet plan based on Mediterranean diet.

Arms, Groups and Cohorts

  • Experimental: EXPERIMENTAL GROUP
  • Other: CONTROL GROUP

Clinical Trial Outcome Measures

Primary Measures

  • Sleep Quality
    • Time Frame: 16 weeks
    • Sleep Quality assessment: Athenas Insomnia Scale.
  • Anxiety trait
    • Time Frame: 16 weeks
    • Anxiety trait assessment: Stay Trait Anxiety Inventory.
  • Mood state
    • Time Frame: 16 weeks
    • Mood state assessment: Profile of Mood State inventory.

Secondary Measures

  • Body composition
    • Time Frame: 16 weeks
    • Body composition assessment trough bioimpedance.

Participating in This Clinical Trial

Inclusion Criteria

  • Women aged 40-60 with fibromialgia (officially diagnosed).

Exclusion Criteria

  • Women used analgesics, vitamins containing supplements, and or other drugs for the treatment of fibromyalgia symptoms, or participation in other clinical trials.

Gender Eligibility: Female

Minimum Age: 40 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alicante
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dr. Alejandro Martínez-Rodríguez, Assistant Professor – University of Alicante

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