An open label pilot study to evaluate the effectiveness of a proprietary krill oil formulation in the relief of troublesome symptoms of the menopause
| ISRCTN | ISRCTN16288792 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16288792 |
| Secondary identifying numbers | Nat1 |
- Submission date
- 27/04/2016
- Registration date
- 23/06/2016
- Last edited
- 15/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Scientific
The Orchards
Fenny Bentley
DE6 1LB
United Kingdom
Study information
| Study design | Prospective open-label evaluation |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2015 |
| Completion date | 01/09/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2015 |
| Date of final enrolment | 30/04/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Station Road
Hook
RG27 9LT
United Kingdom
Sponsor information
Industry
The Orchards
Fenny Bentley
DE6 1LB
United Kingdom
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2016 | 15/10/2020 | Yes | No |
Editorial Notes
15/10/2020: Publication reference added.
11/09/2019: No publications found, verifying study status with principal investigator.
