Investigation of Krill Oil in Women with Premenstrual Syndrome

September 2, 2024 updated by: Aker BioMarine Human Ingredients AS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
179

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Daily from baseline to study completion, up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measurement of total DRSP score in mid follicular phase
Time Frame: Daily from baseline to study completion, up to 6 months
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.
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
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.
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
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.
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.
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.
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
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.
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
Tracks the number of analgesic doses taken daily by participants. This measure reflects the overall usage of pain relief medication throughout the study.
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
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.
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
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.
Daily from baseline to study completion, up to 6 months
Measurement of Omega-3 Index
Time Frame: Baseline and at 6 months post-intervention
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.
Baseline and at 6 months post-intervention
Measurement of global assessment score at visits 4 and 6
Time Frame: At 4 and 6 months
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.
At 4 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aker BioMarine Human Ingredients AS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 23, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AKBM041H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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