Clinical trial NCT05759936: 4-week Seaweed Supplementation on Menopause Symptoms and Psychological Wellbeing
Official title: Effects of 4-week Seaweed Supplementation on Menopause Symptoms and Psychological Wellbeing - a Randomised, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopausal Syndrome
Menopausal Depression
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Doctor Seaweed
First posted: 2023-03-08
Enrollment: 75
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active vs. placebo
Primary purpose: OTHER

Brief summary: Menopausal symptoms have a substantial effect on quality of life as well as potentially serving as markers for future health. Previous research has suggested that diet can impact menopausal symptoms. Seaweed is marketed as a treatment to alleviate menopause symptoms, but no research has tested whether it is effective in reducing the symptoms and psychological effects associated with menopause.

The aim of this study is to investigate the effects of consuming a seaweed supplement over a 4-week time period on menopausal symptoms and psychological well-being.

Detailed description: Menopause and peri-menopause are associated with a number of symptoms and psychological well-being. Previous literature has found a relationship between diet and menopause management. For example, following the Mediterranean diet consuming a variety of vegetables, fruits, legumes and whole grains has found to improve menopausal symptoms particularly vasomotor symptoms. Few studies have explored the effects of dietary supplements on psychological well-being in menopause. The aim of the study is to explore the impact of an iodine-rich seaweed food supplement on menopause symptoms and mental well-being in those experiencing menopause. Online assessments of symptoms will take place pre-intervention and post-intervention and will be compared to the effects of a placebo.

Eligibility criteria: Inclusion Criteria:

* Self-assess as healthy
* Experienced menopausal or peri-menopausal symptoms in the past 6 months

Exclusion Criteria:

* Are currently taking HRT, anti-depressants, or anti-anxiety medication
* Are lactating or pregnant (or seeking to become pregnant)
* Have a thyroid disorder
* Are currently taking iodine supplements
* Have any relevant food intolerances

Primary outcomes:
measure: The Menopause-Specific Quality of Life Questionnaire (Hildtich, 1996)
timeFrame: At 28 days post-dose, adjusted for baseline
measure: Centre for Epidemiologic Studies Depression Scale (Radlof, 1997)
timeFrame: At 28 days post-dose, adjusted for baseline
measure: The State-Trait Anxiety Inventory (Spielberger, 1983)
timeFrame: At 28 days post-dose, adjusted for baseline
measure: The Perceived Stress Scale (Cohen et al., 1983)
timeFrame: At 28 days post-dose, adjusted for baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Online
Study officials:
affiliation: Northumbria University
name: Crystal Haskell-Ramsay
role: PRINCIPAL_INVESTIGATOR
References: