Condition category
Signs and Symptoms
Date applied
27/04/2016
Date assigned
23/06/2016
Last edited
23/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
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.

Who can participate?
Women aged between 45 and 59 with problematic menopausal symptoms

What does the study involve?
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.

What are the possible benefits and risks of participating?
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.

Where is the study run from?
Talkhealth Partnership Ltd (UK)

When is the study starting and how long is it expected to run for?
February 2015 to September 2015

Who is funding the study?
Savant Marketing Ltd

Who is the main contact?
Michael Wakeman

Trial website

Contact information

Type

Scientific

Primary contact

Mr Michael Wakeman

ORCID ID

Contact details

The Orchards
Fenny Bentley
DE6 1LB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Nat1

Study information

Scientific title

An open label pilot study to evaluate the effectiveness of a proprietary krill oil formulation in the relief of troublesome symptoms of the menopause

Acronym

Study hypothesis

The primary objective was to evaluate the effectiveness of a supplement in the management of menopausal symptoms. The study hypothesis was that it would significantly reduce the menopausal symptoms and be effective in their management. Primary outcome measure was based upon the scores of the self-assessment MRS questionnaire for symptoms at baseline compared to those at the end of each of the three months and the efficacy measures were assessed using the paired students t-test.

Ethics approval

Because those receiving concurrent treatment for menopause were excluded, and since no new interventions were introduced during the course of the trial, and no personal data identifying any individuals was collected, the study did not meet the criteria necessitating approval from a UK Regional Ethics Committee. However, the protocol did meet the necessary requirements of the investigators' academic institution.

Study design

Prospective open-label evaluation

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Home

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Menopausal symptoms

Intervention

Each dose of the krill oil compound supplement contains thiamine hydrochloride 1.4mg, riboflavin 1.6mg, pyridoxine hydrochloride 2mg, standardised soy isoflavones 50mg-(S101), standardised rosemary extract (S102) 50mg in soft gelatin capsules containing 350mg of krill oil. 2 capsules were taken each day during the active phase of the trial.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Symptom severity was assessed using a Menopause Rating Scale (MRS) which measures menopausal or climacteric symptoms in a standardized way and was validated some years ago. It aims to establish an instrument that measures health-related quality of life that can easily be completed. The original German scale has been translated into English and culturally adapted. Assessed at baseline, 1 month, 2 months and 3 months

Secondary outcome measures

Side effects of the intervention assessed at baseline, 1 month, 2 months and 3 months

Overall trial start date

01/02/2015

Overall trial end date

01/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged between 45 and 59 years old
2. Presenting with a subjective complaint of problematic menopausal symptoms for a minimum of three days per week for a period of at least 3 months
3. Presence of: marked impaired daytime functioning, hot flushes, appetite loss, sleepiness, nausea, dizziness, tiredness, dry mouth, abnormal sweating, constipation, trouble sleeping, nervousness, mood changes, vaginal changes, urinary incontinence

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

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 sleep
3. Presence of major depression or other severe psychopathology
4. Patients receiving HRT, clonidine, SSRI medications (antidepressants), Isoflavone containing supplements, Omega 3 or 6 supplements

Recruitment start date

01/02/2015

Recruitment end date

30/04/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Talkhealth Partnership Ltd
Landmark House Station Road
Hook
RG27 9LT
United Kingdom

Sponsor information

Organisation

Total Health and Wellbeing Ltd

Sponsor details

The Orchards
Fenny Bentley
DE6 1LB
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Savant Marketing Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes