Changes in Muscle Strength, Inflammatory Markers, and Body Composition in Response to Alternate Day Fasting Combined With Krill Oil Supplementation in Adults With Overweight and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in fat-free mass
研究概览
简要总结
The goal of this double-blind, randomised, controlled trial is to determine the effects of LC n-3 PUFAs supplementation on changes in body composition and muscle strength during body weight loss and body weight maintenance among healthy adults living with overweight and obesity. The main research questions:
- Is supplementation with LC n-3 PUFAs during dietary weight loss intervention (alternative-day fasting) attenuate the reduction in fat-free mass and muscle strength?
- Is supplementation with LC n-3 PUFAs during dietary weight loss intervention (alternative-day fasting) provide additional impact on appetite related hormones (Acylated ghrelin, GLP-1, and PYY) and cardiometabolic risk factors (Post prandial inflammatory markers and Triglycerides)? Participants will be randomly assigned to a PLACEBO (Mix-vegetables oil) or LC n-3 PUFAs group (krill oil) (1:1 basis). Both groups will follow a dietary weight loss intervention (Alternate-day fasting).
The study will last for 20 weeks that divided into 3 phases: four weeks of the preparation phase, eight weeks of body weight loss phase (Alternate Day Fasting), followed by eight weeks of body weight maintenance phase (regular diet).
详细描述
During the preparation phase, participants will be asked to take 4g/d krill oil capsules or placebo oil (mixed vegetable oil) with their healthy diet (their usual diet) for a period of 4 weeks. After the completion of the four weeks of the preparation phase, the weight loss intervention (Alternate Day Fasting) will start, and it last for eight weeks. Then, after the weight loss intervention, the weight maintenance phase will start, and it takes a period of 8 weeks until the end of the trial (20 weeks - study completion).
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
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy (male/female)
- •body mass index (BMI) of 25 - 39.9 kg/m2
- •Aged between 25 and 65 years
- •stable body weight for at least three months
排除标准
- •Food allergy
- •On any dietary supplements or dietary regimes at the time of the study
- •Participants with systolic/diastolic <90/60 mmHg and >140/90 mmHg
结局指标
主要结局
Changes in fat-free mass
时间窗: 4 weeks, 12 weeks, and 20 weeks
To assess the effect of supplementation with LCn-3 PUFA during caloric restriction on the changes of fat-free mass. The changes in fat-free mass will be measured by using a deuterium oxide water (D2O) technique. This technique has been used for the past 50 years to estimate total body water (TBW), which is then used to calculate fat-free mass (FFM) in kg. The investigators will take two saliva samples from participants in each visit.
Fat mass
时间窗: 4 weeks, 12 weeks, and 20 weeks
To assess the effect of supplementation with LCn-3 PUFA during caloric restriction on the changes of fat mass. The changes in fat mass will be measured by using a deuterium oxide water (D2O) technique. This technique has been used for the past 50 years to estimate total body water (TBW), which is then used to calculate fat mass in kg. The investigators will take two saliva samples from participants in each visit.
Muscle function by Handgrip strength
时间窗: 4 weeks, 12 weeks, and 20 weeks
The Jamar hydraulic Hand dynamometer, which is a portable instrument used in clinical and research settings to precisely measure grip strength and hand function, will be used to measure handgrip strength. It has an adjustable handle that contains five grip position to suit different hand sizes and preferences. It measures the amount of force that a hand can squeeze around the dynamometer, which in term used to predict the overall muscle strength. The hand-held hydraulic system contains a measurement range of 0 to 200 pounds of force (0 to 90 kilograms), making it appropriate for testing hand grip strength. The dynamometer will be adjusted for participant's hand size. Then, the participant will be asked to perform as much grip pressure as possible for two to three seconds. The subjects will receive verbal guidance from the examiner to start and finish the grip test.
Chair rising test
时间窗: 4 weeks, 12 weeks, and 20 weeks
The chair rising test will be used to asses physical performance. The subjects will be asked to sit on a chair without armrests and perform a rising from a chair to a full standing position (standing fully erect to a straight and upright position) and then sitting down again as quickly as possible five times with recording time, with arms folded across the chest. The chair rising test will be based on seconds (s).
次要结局
- Appetite related hormone [Glucagon-like peptide 1 (GLP-1)](4 weeks, 12 weeks, and 20 weeks)
- Appetite related hormone [ Peptide YY (PYY)](4 weeks, 12 weeks, and 20 weeks)
- Cardiometabolic risk factor (Triglycerides)(4 weeks, 12 weeks, and 20 weeks)
- Appetite related hormone [ Acylated Ghrelin](4 weeks, 12 weeks, and 20 weeks)
- Cardiometabolic risk factor (Insulin)(4 weeks, 12 weeks, and 20 weeks)
- Cardiometabolic risk factor (Glucose)(4 weeks, 12 weeks, and 20 weeks)
研究者
Dr Dalia Malkova
Senior Lecturer Human Nutrition School of Medicine, Dentistry and Nursing College of Medical, Veterinary & Life Sciences University of Glasgow
University of Glasgow