Premenstrual SyndromeNCT06584669
Investigation of Krill Oil in Women with Premenstrual Syndrome
A study testing Krill oil in people with Premenstrual Syndrome, run by Aker BioMarine Human Ingredients AS at 1 site in Germany.
Trial summary
In this study the effects of different dosages and preparations of krill oil in comparison to placebo on symptoms of premenstrual syndrome in healthy, female adults will be assessed. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Krill oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 1 siteGermany
- Study dates
- 23 Feb 2012to 23 Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Age: 20 - 50 years
- Sex: female
- Premenopausal
- Regular menstrual bleeding
- History of and presence of PMS symptoms of at least 6 months
- Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
Who cannot join
- BMI: < 19 kg/m2, ≥ 30 kg/m2
- Heavy smoker >15 cigarettes / day
- Known pregnancy, breast feeding or intention to become pregnant during the course of the study
- No use of acceptable contraceptive method during the study
- Menstrual cycle lasting less than 24 / longer than 35 days
- Hormone treatment because of premenstrual symptoms
Show all 21Show fewer
- Diagnosed premenstrual dysphoric disorder (PMDD), a severe form of PMS
- Regular consumption of omega-3 fatty acids (e.g. nutritional supplements) within previous 3 months or during the study course
- Fish consumption of more than 1 serving of fatty fish (e.g herring, mackerel, salmon) per week
- Relevant allergy or known hypersensitivity against compounds of the study preparations
- Unstable medical illness or relevant history or presence of any medical disorder, potentially interfering with this study (e.g. volunteers having experienced any cardiovascular events such as infarction, angina, surgical endocoronary intervention, stroke in the last 6 months or psychiatric disorders / psychoactive medication)
- Clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
- Intake of medication potentially interfering with this study
- Known malabsorption / maldigestion
- Drug-, alcohol- and medication abuses
- Known HIV-infection
- Known acute or chronic hepatitis B and C infection
- Blood donation within 2 weeks prior to study start (day 1) or during study
- Participation in any other clinical study within the last 30 days prior to study start or during the study
- Any other condition that, based on Investigator's judgement, makes the subject unfit for inclusion into study
- Anticipating any planned changes in lifestyle for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Krill Oil in Women with Premenstrual Syndrome: a Randomized, Placebo-controlled, Double-blind, Parallel Group Study with Different Dosages
In this study the effects of different dosages and preparations of krill oil in comparison to placebo on symptoms of premenstrual syndrome in healthy, female adults will be assessed.
Read the detailed description
The study is a randomized, placebo-controlled, double-blind, parallel group trial, in which the effect of krill oil is investigated in healthy female volunteers showing premenstrual symptoms. The study period covers a time period over 6 menstrual cycles of women under which the first two cycles are recorded to assess baseline conditions followed by a 4-cycle supplementation phase. Volunteers are randomly allocated to the 5 study groups including placebo and 4 different dosages and formulations of krill oil. Over the whole study period, volunteers report daily their symptoms in the validated questionnaire DRSP. Mood state and quality of life are assessed at baseline and after two and 4 cycles of supplementation.
- Conditions
- Premenstrual Syndrome
- Being tested
- Krill oil, Placebo
- Keywords
- inflammation, krill oil, omega-3 fatty acids, premenstrual syndrome
- Medical subject headings
- Premenstrual Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill oilDietary supplement
The krill oil capsules contain Superba™ krill oil extracted from Antarctic krill (Euphausia superba).
PlaceboOther
The placebo capsules contain a medium-chain triglyceride (MCT) oil obtained by fractionation of coconut and palm kernel oil, which has no detectable levels of EPA, DHA, astaxanthin, or phospholipids.
| Study group | Role | What they receive |
|---|---|---|
| 0.5 KO | Active comparator | This group receives 500 mg Krill Oil + 1.5 g medium-chain triglycerides (MCT) Oil daily during a 4-cycle supplementation phase. Receives: Dietary Supplement: Krill oil |
| 1 KO | Active comparator | This group receives 1 g Krill Oil + 1 g MCT Oil daily during a 4-cycle supplementation phase. Receives: Dietary Supplement: Krill oil |
| 2 KO | Active comparator | This group receives 2 g Krill Oil daily during a 4-cycle supplementation phase. Receives: Dietary Supplement: Krill oil |
| 0.5 KO+A | Active comparator | This group receives 500 mg Krill Oil + 2mg astaxanthin + 1.5 g MCT Oil daily during a 4-cycle supplementation phase. Receives: Dietary Supplement: Krill oil |
| Placebo | Placebo comparator | This group receives medium-chain triglyceride (MCT) oil daily during a 4-cycle supplementation phase. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of reduction in premenstrual symptoms in the late luteal phase
Reduction in premenstrual symptoms in the late luteal phase, as measured by the Daily Record of Severity of Problems (DRSP), following supplementation with 2 g krill oil compared to placebo. All other products are assessed as secondary outcomes.
Measured: Daily from baseline to study completion, up to 6 months
Secondary outcomes (10)
Measurement of total DRSP score in mid follicular phase
Measures the overall severity of symptoms using the Daily Rating of Severity of Problems (DRSP) scale during the mid-follicular phase. It combines daily ratings to reflect symptom intensity for this specific phase.
Measured: Daily from baseline to study completion, up to 6 months
Measurement of physical Items Subscore
The Physical Items Subscore assesses the severity and frequency of physical symptoms experienced by participants, such as fatigue, headaches, and muscle pain. These symptoms are evaluated daily using a standardized scale, where each symptom is rated based on intensity and impact on daily functioning. The scores in scale points are combined to create a subscore representing the overall physical symptom burden.
Measured: Daily from baseline to study completion, for up to 6 months
Measurement of mood Items Subscore
This subscore assesses the severity of mood-related symptoms, such as anxiety and irritability, rated daily on a standardized scale. Scores in scale points reflect the overall emotional symptom burden.
Measured: Daily from baseline to study completion, up to 6 months
Measurement of physical Items Subscore
The Physical Items Subscore assesses the severity and frequency of physical symptoms experienced by participants, such as fatigue, headaches, and muscle pain. These symptoms are evaluated daily using a standardized scale, where each symptom is rated based on intensity and impact on daily functioning. The scores in scale points are then combined to create a subscore representing the overall physical symptom burden.
Measured: Daily from baseline to study completion, for up to 6 months.
Measurement of total Score on Q-LES-Q SF
Evaluates overall quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q SF). This score reflects the combined daily assessments of various life satisfaction and enjoyment domains given in scale points.
Measured: Daily from baseline to study completion, up to 6 months
Measurement of quantity of analgesics consumed
Tracks the number of analgesic doses taken daily by participants. This measure reflects the overall usage of pain relief medication throughout the study.
Measured: Daily from baseline to study completion, up to 6 months
Measurement of total mood disturbance score on POMS
Assesses the overall mood disturbance using the Profile of Mood States (POMS) scale. This score given in scale points combines daily ratings to indicate the intensity of mood disturbances experienced by participants.
Measured: Daily from baseline to study completion, for up to 6 months
Measurement of proportion of responders with 50% reduction in late luteal phase symptoms
Measures the percentage of participants who show a 50% reduction in symptoms during the late luteal phase. This reflects the effectiveness of the intervention in alleviating symptoms during this phase.
Measured: Daily from baseline to study completion, up to 6 months
Measurement of Omega-3 Index
Assesses the Omega-3 Index by measuring the percentage of EPA and DHA in red blood cells. This reflects the level of Omega-3 fatty acids, indicating dietary intake and compliance.
Measured: Baseline and at 6 months post-intervention
Measurement of global assessment score at visits 4 and 6
Evaluates overall health and symptom severity during study visits 4 and 6 using a standardized scale. This score reflects participants\' general condition at these specific time points.
Measured: At 4 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start23 Feb 2012
- Primary completion11 Apr 2013
- Study completion23 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blind, parallel group study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aker BioMarine Human Ingredients AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Responsible party
- Sponsor
- Investigators
- Daniel Menzel, PhD, Principal investigator, BioTeSys GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584669
- Sponsor's protocol ID
- AKBM041H
- Status last verified
- Sep 2024
- First submitted
- 28 Aug 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Krill Oil in Women with Premenstrual Syndrome: a Randomized, Placebo-controlled, Double-blind, Parallel Group Study with Different Dosages
- ClinicalTrials.gov ID
- NCT06584669
- Acronym / sponsor ID
- AKBM041H
- Conditions
- Premenstrual Syndrome
- Keywords
- inflammation, krill oil, omega-3 fatty acids, premenstrual syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Aker BioMarine Human Ingredients ASIndustry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Study start
- 23 Feb 2012 (actual)
- Primary completion
- 11 Apr 2013 (actual)
- Study completion
- 23 Aug 2013 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the effects of different dosages and preparations of krill oil in comparison to placebo on symptoms of premenstrual syndrome in healthy, female adults will be assessed.
Detailed description
The study is a randomized, placebo-controlled, double-blind, parallel group trial, in which the effect of krill oil is investigated in healthy female volunteers showing premenstrual symptoms. The study period covers a time period over 6 menstrual cycles of women under which the first two cycles are recorded to assess baseline conditions followed by a 4-cycle supplementation phase. Volunteers are randomly allocated to the 5 study groups including placebo and 4 different dosages and formulations of krill oil. Over the whole study period, volunteers report daily their symptoms in the validated questionnaire DRSP. Mood state and quality of life are assessed at baseline and after two and 4 cycles of supplementation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Randomized, placebo-controlled, double-blind, parallel group study
| Arm | Type | Receives |
|---|---|---|
| 0.5 KO | Active comparator | Dietary Supplement: Krill oilThis group receives 500 mg Krill Oil + 1.5 g medium-chain triglycerides (MCT) Oil daily during a 4-cycle supplementation phase. |
| 1 KO | Active comparator | Dietary Supplement: Krill oilThis group receives 1 g Krill Oil + 1 g MCT Oil daily during a 4-cycle supplementation phase. |
| 2 KO | Active comparator | Dietary Supplement: Krill oilThis group receives 2 g Krill Oil daily during a 4-cycle supplementation phase. |
| 0.5 KO+A | Active comparator | Dietary Supplement: Krill oilThis group receives 500 mg Krill Oil + 2mg astaxanthin + 1.5 g MCT Oil daily during a 4-cycle supplementation phase. |
| Placebo | Placebo comparator | Other: PlaceboThis group receives medium-chain triglyceride (MCT) oil daily during a 4-cycle supplementation phase. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Age: 20 - 50 years
- Sex: female
- Premenopausal
- Regular menstrual bleeding
Key exclusion criteria (21 listed)
- BMI: < 19 kg/m2, ≥ 30 kg/m2
- Heavy smoker >15 cigarettes / day
- Known pregnancy, breast feeding or intention to become pregnant during the course of the study
- No use of acceptable contraceptive method during the study
- Menstrual cycle lasting less than 24 / longer than 35 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Krill oilThe krill oil capsules contain Superba™ krill oil extracted from Antarctic krill (Euphausia superba). | Dietary supplement | 0.5 KO, 0.5 KO+A, 1 KO, 2 KO |
| PlaceboThe placebo capsules contain a medium-chain triglyceride (MCT) oil obtained by fractionation of coconut and palm kernel oil, which has no detectable levels of EPA, DHA, astaxanthin, or phospholipids. | Other | Placebo |
Primary outcome
Measurement of reduction in premenstrual symptoms in the late luteal phase
Time frame: Daily from baseline to study completion, up to 6 months
Reduction in premenstrual symptoms in the late luteal phase, as measured by the Daily Record of Severity of Problems (DRSP), following supplementation with 2 g krill oil compared to placebo. All other products are assessed as secondary outcomes.
10 secondary outcomes
Measurement of total DRSP score in mid follicular phase
Time frame: Daily from baseline to study completion, up to 6 months
Measurement of physical Items Subscore
Time frame: Daily from baseline to study completion, for up to 6 months
Measurement of mood Items Subscore
Time frame: Daily from baseline to study completion, up to 6 months
Measurement of physical Items Subscore
Time frame: Daily from baseline to study completion, for up to 6 months.
Measurement of total Score on Q-LES-Q SF
Time frame: Daily from baseline to study completion, up to 6 months
Measurement of quantity of analgesics consumed
Time frame: Daily from baseline to study completion, up to 6 months
Measurement of total mood disturbance score on POMS
Time frame: Daily from baseline to study completion, for up to 6 months
Measurement of proportion of responders with 50% reduction in late luteal phase symptoms
Time frame: Daily from baseline to study completion, up to 6 months
Measurement of Omega-3 Index
Time frame: Baseline and at 6 months post-intervention
Measurement of global assessment score at visits 4 and 6
Time frame: At 4 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Menzel, PhD principal investigator
BioTeSys GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Krill oil in people with Premenstrual Syndrome, run by Aker BioMarine Human Ingredients AS at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of reduction in premenstrual symptoms in the late luteal phase (time frame: Daily from baseline to study completion, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.