Investigation of Krill Oil in Women with Premenstrual Syndrome
NCT Number: NCT06584669
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Premenstrual Syndrome
Sponsor: Aker BioMarine Human Ingredients AS
Sex: FEMALE
Age: ADULT
Enrollment: 179
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2012-02-23
Completion Date: 2013-08-23

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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., 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., 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., Daily from baseline to study completion, for up to 6 months.|Measurement of total Score on Q-LES-Q SF, 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, 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, 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, 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, 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, Evaluates overall health and symptom severity during study visits 4 and 6 using a standardized scale. This score reflects participants\&#39; general condition at these specific time points., At 4 and 6 months