Investigation of Krill Oil in Women with Premenstrual Syndrome: a Randomized, Placebo-controlled, Double-blind, Parallel Group Study with Different Dosages
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Measurement of reduction in premenstrual symptoms in the late luteal phase
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
This group receives medium-chain triglyceride (MCT) oil daily during a 4-cycle supplementation phase.
干预措施: Placebo (Other)
0.5 KO+A
This group receives 500 mg Krill Oil + 2mg astaxanthin + 1.5 g MCT Oil daily during a 4-cycle supplementation phase.
干预措施: Krill oil (Dietary Supplement)
2 KO
This group receives 2 g Krill Oil daily during a 4-cycle supplementation phase.
干预措施: Krill oil (Dietary Supplement)
1 KO
This group receives 1 g Krill Oil + 1 g MCT Oil daily during a 4-cycle supplementation phase.
干预措施: Krill oil (Dietary Supplement)
0.5 KO
This group receives 500 mg Krill Oil + 1.5 g medium-chain triglycerides (MCT) Oil daily during a 4-cycle supplementation phase.
干预措施: Krill oil (Dietary Supplement)
结局指标
主要结局
Measurement of reduction in premenstrual symptoms in the late luteal phase
时间窗: Daily from baseline to study completion, up to 6 months
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.
次要结局
- Measurement of global assessment score at visits 4 and 6(At 4 and 6 months)
- 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 total Score on Q-LES-Q SF(Daily from baseline to study completion, up to 6 months)
- Measurement of quantity of analgesics consumed(Daily from baseline to study completion, up to 6 months)
- Measurement of total mood disturbance score on POMS(Daily from baseline to study completion, for up to 6 months)
- Measurement of proportion of responders with 50% reduction in late luteal phase symptoms(Daily from baseline to study completion, up to 6 months)
- Measurement of Omega-3 Index(Baseline and at 6 months post-intervention)
- Measurement of physical Items Subscore(Daily from baseline to study completion, for up to 6 months)