Bioavailability of Micronutrients With a Special Focus on Vitamin K - Study Part I: K-vitamin
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 13C-labelled vitamin K vitamers in blood samples
研究概览
简要总结
Objectives
The main objectives are:
Study part I: to investigate the bioavailability of vitamin K vitamers (PK, MK-4, MK-7 and MK-9) in humans using 13C-labelled compounds
Hypotheses Study part I: it is hypothesized that there is a difference between the bioavailability of the different vitamers, with MK-9 having the highest bioavailability followed by MK-7, and then PK, while MK-4 will have the lowest bioavailability.
Participants will:
Study part I: In the pilot study and study part I, participants will visit NEXS for a test period where a 6.5-hour test day will be carried out and followed up with two short visits on the 2 consecutive days. In the pilot study, there will be one test period with frequent blood sampling (before and after ingestion of a labelled vitamin K vitamer) and urine and faeces sampling. The minimum duration for each participant in the pilot study will be 2.5 weeks. After analyses of the bioavailability of the vitamin K vitamers in the pilot study, results will be used to determine the time points for biological sampling (mainly blood) in study part I. Study part I is a cross-over study with 4 test periods and washout periods in between. The minimum duration for each participant will be 6 weeks.
详细描述
Overall study design Pilot study (n= 2 completers): An acute postprandial randomised parallel study comparing the bioavailability of two forms of labelled vitamin K vitamers (13C-PK and 13C-MK-7) Study part I (n= 16 completers): An acute postprandial randomised cross-over study comparing the bioavailability of four forms of labelled vitamin K vitamers (13C-PK, 13C-MK-4, 13C-MK-7, and 13C-MK-9)
Detailed study design of pilot study and part I Prerequisites
Prior to the first test period (day 0) the participants will be asked to:
- 2 weeks before: supplement with 10 µg vitamin D3/day (recommended daily intake) and restrain from all other types of (vitamins and mineral) supplementation
- 1 week before: not consume sweet corns, beetroot and spinach
- 48 hours before: alcohol intake is prohibited
- 24 hours before: high-intensity physical activity is prohibited
- 12 hours before: except 0.5 L tap water, consumption of drinks and foods are not allowed After the first test day and during the remaining part of the study, the participants are asked to refrain from consumption of sweet corn, beetroot and spinach, continue supplementation with vitamin D. Before all days with blood sampling (3 first days in a test period), the above prerequisites related to alcohol intake, high-intensity physical activity and fasting are applicable.
Test periods A baseline description (e.g. anthropometry, blood pressure and fasting values) of the participants will be established prior to and on the first test day (Day 0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men and women
- •Between 18 and 65 years old (including both 18 and 65 year olds)
- •Danish-speaking
- •Willingness to consume/comply with consumption of study-related intervention products/diet
- •Willing to take 10 µg vitamin D3/day and omit intake of all other (vitamins and mineral) supplements before and during the trial
- •BMI ≤ 30.0 kg/m2
排除标准
- •Daily smokers/users of all kinds of nicotine-containing products. Occasional smokers/user can be included if they are willing to refrain from all kinds of nicotine-containing products during the trial (from screening to end of trial)
- •Blood donation <3 months prior to study-related blood sampling
- •Intensive physical training (> 10 hours of strenuous physical activity per week)
- •Participation in other clinical studies at the time of the study
- •Pregnant, lactating or planning to become pregnant within the study period
- •Habitual alcohol intake above current recommendation (> 10 alcoholic units/week)
- •History of cancer within the past five (5) years except basal cell skin cancer and cervix
- •Diagnosed with chronic inflammation disorders
- •Diagnosed with gastrointestinal diseases
- •Diagnosed with bone related diseases
- •Diagnosed with psychiatric disorder including depression that requires medical treatment
- •Medical treatment of diabetes
- •Medical treatment of cardiovascular related disease
- •Surgical change of the gastrointestinal tract (removal of appendix is allowed)
- •Use of prescription medication that can affect their safety or impact on data
- •Inability, physically or mental, to comply with the procedure required by the study protocol and evaluated by the principal investigator (PI), study manager or clinical responsible
- •Medical treatment with anticoagulation medication (warfarin-like types)
- •Allergy or intolerance related to intervention products
结局指标
主要结局
13C-labelled vitamin K vitamers in blood samples
时间窗: from test day 1 until the end of the last washout period 5 weeks after test day 1.
The area under the curve for the different 13C-labelled vitamin K vitamers will be compared from blood samples.
13C-labelled vitamin K vitamers in fecal samples
时间窗: from test day 1 until the end of the last washout period 5 weeks after test day 1.
The amount of 13C-labelled vitamin K vitamers in the feces will be analysed
13C-lebelled vitamin K vitamers in urine samples
时间窗: from test day 1 until the end of the last washout period 5 weeks after test day 1.
The amount of 13C-labelled vitamin K vitamers in the urine will be analysed
次要结局
未报告次要终点
研究者
Susanne Bügel
Professor, Head of Section
University of Copenhagen