Investigation of Krill Oil in Women with Premenstrual Syndrome

Aker BioMarine Human Ingredients AS179 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

179

Conditions

Premenstrual Syndrome

Interventions

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

BioTeSys GmbH

Esslingen am Neckar, Germany

Outcomes

Primary Outcomes

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.

Time frame: Daily from baseline to study completion, up to 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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