4-week Seaweed Supplementation on Menopause Symptoms and Psychological Wellbeing

NCT05759936 | Completed

• 1 other identifier: Project ID 2434
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopausal Syndrome; Menopausal Depression

Outcome Measures

Primary Outcomes (4)

• The Menopause-Specific Quality of Life Questionnaire (Hildtich, 1996)

  The menopause-specific quality of life questionnaire 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 physical 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.

  At 28 days post-dose, adjusted for baseline

• 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.

  At 28 days post-dose, adjusted for baseline

• The State-Trait Anxiety Inventory (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'.

  At 28 days post-dose, adjusted for baseline

• 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.

  At 28 days post-dose, adjusted for baseline

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsule consumed for 28 days

Other: Placebo

500mg seaweed

EXPERIMENTAL

Seaweed capsule consumed for 28 days

Dietary Supplement: 500mg seaweed

Interventions

500mg seaweed DIETARY_SUPPLEMENT

4 week supplementation of 1 capsule per day of seaweed

500mg seaweed

Placebo OTHER

4 week placebo supplement of 1 capsule per day

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• Doctor Seaweed: collaborator

Study Sites (1)

Online

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

Study Officials

• Crystal Haskell-Ramsay

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Active vs. placebo

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 8, 2023
• Study Start: March 20, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: March 21, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available 3 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Fully accessible

Locations

GB (1)