4-week Seaweed Supplementation on Menopause Symptoms and Psychological Wellbeing

NCT ID: NCT05759936

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2023-12-12

Brief Summary

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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

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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.

Conditions

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Menopausal Syndrome Menopausal Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Active vs. placebo
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo capsule consumed for 28 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

4 week placebo supplement of 1 capsule per day

500mg seaweed

Seaweed capsule consumed for 28 days

Group Type EXPERIMENTAL

500mg seaweed

Intervention Type DIETARY_SUPPLEMENT

4 week supplementation of 1 capsule per day of seaweed

Interventions

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500mg seaweed

4 week supplementation of 1 capsule per day of seaweed

Intervention Type DIETARY_SUPPLEMENT

Placebo

4 week placebo supplement of 1 capsule per day

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Doctor Seaweed

UNKNOWN

Sponsor Role collaborator

Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Crystal Haskell-Ramsay

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

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Online

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Project ID 2434

Identifier Type: -

Identifier Source: org_study_id

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