Investigation of Krill Oil in Women with Premenstrual Syndrome

NCT06584669 | Completed

• 1 other identifier: AKBM041H
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premenstrual Syndrome

Keywords

inflammation; krill oil; omega-3 fatty acids; premenstrual syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  Daily from baseline to study completion, up to 6 months

Secondary Outcomes (10)

• Measurement of total DRSP score in mid follicular phase

  Daily from baseline to study completion, up to 6 months

• Measurement of physical Items Subscore

  Daily from baseline to study completion, for up to 6 months

• Measurement of mood Items Subscore

  Daily from baseline to study completion, up to 6 months

• Measurement of physical Items Subscore

  Daily from baseline to study completion, for up to 6 months.

• Measurement of total Score on Q-LES-Q SF

  Daily from baseline to study completion, up to 6 months

Study Arms (5)

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.

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.

Dietary Supplement: Krill oil

2 KO

ACTIVE COMPARATOR

This group receives 2 g Krill Oil daily during a 4-cycle supplementation phase.

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.

Dietary Supplement: Krill oil

Placebo

PLACEBO COMPARATOR

This group receives medium-chain triglyceride (MCT) oil daily during a 4-cycle supplementation phase.

Other: Placebo

Interventions

Krill oil DIETARY_SUPPLEMENT

The krill oil capsules contain Superba™ krill oil extracted from Antarctic krill (Euphausia superba).

0.5 KO; 0.5 KO+A; 1 KO; 2 KO

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aker BioMarine Human Ingredients AS: lead
• BioTeSys GmbH: collaborator

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, Germany

Location

MeSH Terms

Conditions

Premenstrual Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Menzel, PhD

  BioTeSys GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All participants and study staff were blinded to treatment allocations until the last patient had completed the last visit. The study capsules were identical in shape and color and packed in blisters tailor-made for each intervention group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blind, parallel group study

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 5, 2024
• Study Start: February 23, 2012
• Primary Completion: April 11, 2013
• Study Completion: August 23, 2013
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

DE (1)