NCT06584669

Investigation of Krill Oil in Women with Premenstrual Syndrome

Investigation of Krill Oil in Women with Premenstrual Syndrome: a Randomized, Placebo-controlled, Double-blind, Parallel Group Study with Different Dosages

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Aker BioMarine Human Ingredients AS · Industry
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Krill oil	The krill oil capsules contain Superba™ krill oil extracted from Antarctic krill (Euphausia superba).
OTHER	Placebo	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.

Timeline

• Start date: 2012-02-23
• Primary completion: 2013-04-11
• Completion: 2013-08-23
• First posted: 2024-09-05
• Last updated: 2024-09-05

Locations

1 site across 1 country: Germany