Open, Fixed Sequence Diet-switch 4-week Intervention on the Effects of Brain-friendly Diet on Metabolic and Physiological Parameters and Cognitive Performance in Office Workers at Assumed Metabolic Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in LDL cholesterol
研究概览
简要总结
To evaluate the effect of dietary intervention on metabolic risk profile, and on potential simultaneous changes in physiological and cognitive functions and to collect a unique database using state-of-the-art technologies on variables related to the above mentioned areas.
详细描述
The study is compiled from 4 phases: 1) a pilot study to evaluate performance and feasibility of the measurements and logistics for the BRAVE intervention study (N=10), 2) a pre-screening phase to select volunteers for the intervention study based on metabolite analyses (N=600), 3) the BRAVE intervention study as a controlled non-randomized open-label fixed sequence diet switch trial (N=88)and 4) a non-interventional reference group to estimate the learning effect due to repeated cognitive testing (N=30).
The Brainfood dietary regime is planned optimal for metabolism and cognitive function; having focus on regular meal frequency (breakfast, lunch and afternoon snack) and well-balanced light lunch at work -according to the so-called plate model and optimized recipes- will be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent
- •Age 18-65 years
- •Assumed metabolic risk based on pre-screening assessment of glucose and lipid metabolism related metabolites defined initially as being within the most impaired quartile with reference to available metabolite data-base from a comparable population. If recruitment efficiency requires, having a metabolic profile within the most impaired half instead of a quartile may be applied.
- •Male or female with at least 1/3 of the gender defined predominant among screened participants with assumed metabolic risk
- •Adequate Finnish or English skill to comprehend trial related instructions and questionnaires
- •Chest circumference of 75 to 115 cm (limits included)
排除标准
- •High probability to travel for more than one working day a week during the trial
- •Expected or planned major changes in lifestyle (diet, level of exercise, significant changes in work) or involved in the R&D of the measuring devices applied in the trial
- •Allergies restricting compliance with control or intervention diet (celiac disease, gluten free diet, stringent FODMAP diet)
- •Nickel allergy
- •History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), temporal ischemic attack within the previous 6 months
- •Diagnosed type 1 or type 2 diabetes requiring treatment
- •Inflammatory bowel disease or other intestinal or oesophageal disease requiring medical treatment or likely to have a nutritional affect
- •History of malignant diseases like cancer within five years prior to recruitment
- •Lipid lowering medication (statin, cholestyramine) or medication for obesity (orlistat, or liraglutide) or depression
- •Alcohol abuse (> 4 portion/per day) or recreational drug abuse
- •Pregnancy or planned pregnancy or lactating
- •Suspected low compliance according to the investigator's assessment
研究组 & 干预措施
Control diet
Regular diet
干预措施: Control diet (Other)
Intervention diet
Brainfood diet
干预措施: Intervention diet (Other)
结局指标
主要结局
Change in LDL cholesterol
时间窗: 8 weeks
Change in serum LDL concentration between control period and intervention period
次要结局
- Change in serum metabolite concentrations(8 weeks)
- Change in cognitive performance(4 weeks)
- Changes in self-reported vigilance(4 weeks)
- Changes in self-reported task load(4 weeks)
- Daily pulse profile (evening- night- morning)(8 weeks)
- Daily profile of heart rate variability (evening- night- morning)(8 weeks)
- Number of adverse events(8 weeks)
- Change in dietary habits and nutrient intake(8 weeks)