12-week Magnesium Supplementation on Peri-menopause Symptoms, Cognition, Sleep, and Psychological Well-being
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorNorthumbria University
About this trial
Perimenopause is a transition phase into menopause, characterised by menopausal symptoms while menstrual periods are still occurring. Common symptoms of perimenopause include hot flushes, night sweats, mood swings, anxiety, sleep disturbances, fatigue, and cognitive difficulties. These symptoms can be both frequent and intense, with the potential to significantly deteriorate women's quality of life. Despite an increase in public discourse around menopause, there are still large gaps in knowledge. Previous literature has suggested a relationship between diet and menopause management. However, studies in this area are limited and women often rely on social media for advice on supplements to address menopause complaints. One supplement that has received a lot of attention with purported benefits for menopause is magnesium, primarily due to its links to energy and or/sleep, however no studies have explored psychological effects of magnesium supplementation in perimenopause.
The aim of this study is to explore the effects of 12-weeks magnesium supplementation on perimenopause symptoms, cognition, sleep, and psychological well-being.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Self-assess as healthy
Report experiencing troublesome peri-menopause symptoms in the past 6 months but not post-menopausal (defined as 12 months with no periods)
Disqualifiers
Post-menopausal
Lactating, pregnant or seeking to become pregnant
Nut Allergy
Taken antidepressant/antianxiety medication or other medication with strong likelihood for effects on cognition or sleep in the past 6 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
Other intervention12 week placebo supplement of 2 capsules per day
Magnesium hydroxide 375mg
Dietary supplement12 week supplementation of 2 capsules per day of Magnesium hydroxide
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: 375mg magnesium hydroxideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Numeric working memory task % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
Time frame
Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.2
Numeric working memory task reaction time
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Time frame
Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.3
3-back task % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
Time frame
Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.4
3-Back task reaction time
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Time frame
Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.Secondary outcomes
1
The Menopause-Specific Quality of Life Questionnaire (Hilditch, 1996)
Assesses the effect of menopausal symptoms on quality of life in four domains: vasomotor, psychosocial, physical, and sexual; as well as providing a total score. The questionnaire has 29 items, each item is a symptom of menopause, the participants rate each symptom between 0 (not at all bothered) to 6 (bothered all the time.) The vasomotor symptoms include items such as 'hot flushes' and 'sweating'; psychological symptoms include 'accomplishing less than I used to' and 'poor memory'; physical symptoms include 'difficulty sleeping' and 'weight gain'; sexual symptoms include 'vaginal dryness' and 'avoiding intimacy'. A conversion score is created for each of the 4 domains: vasomotor; psychosocial; physical; sexual; as well as a total score. Each score ranges from 1 -8, with higher scores indicating greater problems.
Time frame
Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.2
Centre for Epidemiologic Studies Depression Scale (Radlof, 1997)
This is an established questionnaire used to measure symptoms associated with depression. The questionnaire has 20 items, including 'my sleep is restless', 'I felt depressed' and 'I felt lonely'. The participants rate the symptom on a scale between \<1 day and 5 to 7 days, the 4 scale points are: Rarely or none of the time (less than 1 day); Some or a little of the time (1-2 days); Occasionally or a moderate amount of time (3-4 days); Most or all of the time (5-7 days). The possible range of scores is between 0 to 60, higher scores indicate more presence of symptomatology. The scoring of positive items is reversed.
Time frame
Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.3
The State-Trait Anxiety Inventory, TRAIT subscale (Spielberger, 1983)
The state-trait anxiety inventory will be used to measure anxiety levels, specifically trait anxiety. It consists of 20 items and the scale ranges from 1 to 4: 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always. The nine positive items will be reversed for scoring, items 21, 23, 26, 27, 30, 33, 34, 36 and 39. The possible range of scores is 20 to 80, higher scores indicate higher levels of trait anxiety within the participant. Examples of items within the questionnaire include: 'I feel like a failure' and 'I feel secure'.
Time frame
Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.4
The Perceived Stress Scale (Cohen et al., 1983)
This established questionnaire will be used to measure the perception of stress. Each of the ten items are rated on a scale between 0 (never) to 4 (very often.) The five scale points are 0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often. The four positive items will be reversed for scoring, items 4, 5, 7 and 8. The questionnaire item examples include 'In the last month, how often have you been upset because of something that happened unexpectedly?' and 'In the last month, how often have you felt that you were unable to control the important things in your life?'. The possible range of scores is between 0 to 40, higher scores indicate high participant perceived stress.
Time frame
Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Northumbria University
Lead sponsor
Vitabiotics
Collaborator
Source ClinicalTrials.gov