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Contact Information:

Mr Michael Wakeman


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Be Part of Research - Trial Details - An open label pilot study to evaluate the effectiveness of a proprietary krill oil formulation in the relief of troublesome symptoms of the menopause
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An open label pilot study to evaluate the effectiveness of a proprietary krill oil formulation in the relief of troublesome symptoms of the menopause

Not Recruiting

Open to: Female

Age: Adult

Hook

Medical Conditions

Menopausal symptoms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Around 80% of women experience some symptoms during the menopause, typically lasting about 4 years after the last period, but continuing for up to 12 years in about 10% of women. Those symptoms include vasomotor symptoms (hot flushes and night sweats), vulvovaginal atrophy/dyspareunia, sleep disturbance, adverse mood, a lack of interest in sex, headaches, joint and muscle stiffness, memory and concentration loss, and consequently quality of life may be severely affected. Treatments used to relieve menopause-related symptoms include lifestyle advice, hormone replacement therapy (HRT), antidepressants, herbal remedies, and other complimentary/alternative therapies. Given the issues with the potential safety and side effects of many prescribed medications, the lack of effectiveness of a number of lifestyle interventions, and the clear desire from many women to initially use more natural approaches, there is a need for an effective nutritional solution for managing menopausal symptoms. Several approaches using dietary supplements have been investigated and some were found to be beneficial, but none have investigated the benefits of combining them together. The aim of this study is to assess the effectiveness of a proprietary formulation of ingredients which individually have been shown to relieve the most troublesome symptoms of the menopause. The supplement provides thiamine, riboflavin, pyridoxine, vitamin D, soy isoflavones, rosemary extract and krill oil, and was previously studied in PMS and found to be highly effective in terms of relieving symptoms similarly common in menopause, such as anxiety, fatigue, forgetfulness, insomnia and headache.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Feb 2015 30 Apr 2015

Publications

2016 Results article in https://www.worldwidejournals.com/international-journal-of-scientific-research-(IJSR)/article/an-open-label-pilot-study-to-evaluate-the-effectiveness-of-a-proprietary-krill-oil-formulation-in-the-relief-of-troublesome-symptoms-of-the-menopause/ODY3NQ==/?is=1 results (added 15/10/2020)

Participants take two capsules of the supplement each day with meals for 3 months, and are instructed not to make significant changes to their usual diet. Participants are asked to complete a questionnaire over each of the following 3 months of the study, and rank the impact of the menopausal symptoms they experience.


Women aged between 45 and 59 with problematic menopausal symptoms

You can take part if:



You may not be able to take part if:


1. Evidence that menopausal symptoms are directly related to a severe or unstable medical disorder or severe psychiatric disorder (e.g.,bipolar disorder, schizophrenia)2. Presence of sleep apnea or periodic limb movements during sleep3. Presence of major depression or other severe psychopathology4. Patients receiving HRT, clonidine, SSRI medications (antidepressants), Isoflavone containing supplements, Omega 3 or 6 supplements


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Talkhealth Partnership Ltd
    Landmark House Station Road
    Hook
    RG27 9LT

The benefits are that participants may experience an improvement in the troublesome symptoms of the menopause. The assessments of menopausal symptoms are not invasive. Krill oil has been demonstrated to be a completely safe form of Omega 3 supplementation. The herbs and vitamins which are also ingredients in this formulation have also been demonstrated to be safe. Because krill oil is derived from a crustacean, people with an allergy to shellfish were advised not to participate in the study. Those taking anticoagulants were not allowed to participate in this study.

Mr Michael Wakeman



The study is sponsored by Total Health and Wellbeing Ltd and funded by Savant Marketing Ltd.



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Read full details for Trial ID: ISRCTN16288792
Last updated 15 October 2020

This page is to help you find out about a research study and if you may be able to take part

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