The Effect of Krill Oil Supplementation on Muscle Function in Adults With High-risk Long-term Conditions: a Randomized Controlled Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Grip strength
研究概览
简要总结
This study will recruit 30 adults (men and women, aged 18 years and over) who will be randomly assigned to one of two groups in a 12-week double-blind pilot trial. Participants will receive either:
- Arm 1: Krill Oil group: 4 g/day of krill oil supplements (Superba™ Antarctic Krill Oil, 1000 mg capsules), or
- Arm 2: Control group: 4 g/day of placebo (vegetable oil capsules).
Participants will be instructed to maintain their usual diet and physical activity patterns throughout the study.
Eligibility will be assessed using a health screening questionnaire, completed with the researcher's assistance, before obtaining informed consent. Habitual physical activity will be evaluated using the International Physical Activity Questionnaire (short form), and dietary intake will be assessed with the EPIC Food Frequency Questionnaire (FFQ) at both the beginning and end of the study. In addition, participants will record their fish consumption weekly using a dedicated logbook.
Measurements will be taken at baseline and after 12 weeks, including:
- Blood samples to assess inflammatory and metabolic markers.
- Anthropometry and body composition, including weight, height, fat mass, fat percentage, and muscle mass (via ultrasound).
- Muscle strength, measured using handgrip strength and maximal voluntary contraction (each performed three times with rest between attempts).
- Physical performance, assessed with a 4-meter walk test at normal speed Upon completing the study, participants will receive a £50 voucher in appreciation of their contribution.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged ≥18 years who are in the high-risk long-term condition group (having one or more LTCs, including rheumatoid arthritis, gout, type 2 diabetes, coronary heart disease, and stroke [including transient ischemic attack, TIA]).
排除标准
- •Participants are diagnosed with and being treated for any type of cancer.
- •Presence of neurocognitive disorders or any health condition affecting memory (e.g., Alzheimer's disease, dementia).
- •Aortic stenosis, history of haemorrhagic stroke, or presence of aneurysms.
- •Current anticoagulant therapy.
- •Use of any muscle mass supplements or presence of physiological conditions such as pregnancy or breastfeeding.
- •History of allergy to fish or fish oil.
- •Regular consumption of more than one portion of oily fish per week, or use of fish oil or krill oil supplements.
结局指标
主要结局
Grip strength
时间窗: Changes from baseline to week 12
Measured using a handgrip dynamometer
次要结局
- Knee extendor Strength(Changes from baseline to week 12)
- Muscle size, assessed as vastus lateralis muscle thickness by ultrasound(Changes from baseline to week 12)
- Gait speed(From baseline to week 12)
- Fatty Acid Composition(From baseline to week 12)
- Inflammatory and metabolic markers(From baseline to week 12)
- Height(Changes from baseline to week 12)
- Bodyweight(Changes from baseline to week 12)
- Body Fat Percentages(Changes from baseline to week 12)
- Body Mass Index (BMI)(Changes from baseline to week 12)
- Body Fat Mass(Changes from baseline to week 12)
- Fat Free Mass(Changes from baseline to week 12)
研究者
Stuart Gray
Professor Stuart Gray
University of Glasgow