Investigation of Krill Oil in Women with Premenstrual Syndrome

Aker BioMarine Human Ingredients AS

Status

Completed

Conditions

Premenstrual Syndrome

Study type

Interventional

Funder types

Industry

Identifiers

NCT06584669

AKBM041H

Details and patient eligibility

About

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.

Full 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.

Enrollment

179 patients

Sex

Female

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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