Beta-Cryptoxanthin (BCX) Supplementation and Circulating Carotenoid Concentrations in Women: A Randomized, Controlled, Double-blinded and 8 Week Parallel Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in plasma concentration of BCX over 8 weeks
研究概览
简要总结
Beta-cryptoxanthin (BCX) is a naturally occurring member of the carotenoid family, found in a wide range of fruits and vegetables. The unique biological functions of BCX have not been well-established, although BCX, like other members of the carotenoids have antioxidant functions. BCX, may also serve as a precursor of Vitamin A. Vitamin A has a wide range of functions including maintain immunity, vision, growth and development. Whilst not specific for BCX, epidemiological studies indicate that dietary intake of carotenoids may be of benefit in maintaining cognitive health and reducing stress via its antioxidant, anti-inflammatory and immunomodulatory properties. This pilot study aims to establish the relationship between supplemental dose and circulating concentrations of BCX and related carotenoids in circulation. Results obtained from this study will provide greater insight of bioavailability and carotenoid metabolism, necessary for larger supplementation in selected target populations.
详细描述
In previous Singapore maternal and child health cohort study, Growing up towards healthy outcomes (GUSTO), it established potentially significant health function to be significantly correlated with BCX. At childbirth, mothers' blood concentrations of carotenoids, including α-, β-carotene and BCX were simultaneously measured by ultra-performance liquid chromatography. Unique to the carotenoids, there was a correlation between higher maternal plasma concentrations of BCX with lower rates of depression and reduced anxiety scores during pregnancy for the mother. Furthermore, the concentrations of BCX were uniquely correlated with child neurocognitive function by age 2 years.
Current studies have only been food-based efficacy trials with an increase of dietary BCX intake through BCX-rich foods in humans. There have been no direct assessments of risk associated with BCX exposure, and current evidence in the literature does not identify any consistent, substantial risks for any level of BCX supplementation. Overall, the utility of BCX as a pro-vitamin A is clear, but evidence towards benefits beyond this role is inconsistent.
Hence, this is a pilot study that will aim to examine bioavailability of a novel BCX preparation supplemented at 2 doses (3mg and 6mg daily) versus placebo, consumed once daily in a randomised, doubled-blinded parallel trial, in healthy female subjects of reproductive age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 21 - 35 years old, residing in Singapore
- •Body mass index (BMI) between 18.5 to 27.5 kg/m2
- •Subject should not be pregnant or breastfeeding during study period
- •Subject should not be planning to conceive within 3 months from enrolment
- •Subject must voluntarily consent to participate in this study and provide their written informed consent prior to start of study
- •Subject is always willing to comply with study regulations and instructions
排除标准
- •Any current diagnosis or history of cardiovascular, hepatic, renal, metabolic (e.g. diabetes), immunological, gastrointestinal diseases, psychiatric disorders or chronic diseases
- •Participation in another simultaneous clinical study
- •Ongoing adherence to weight reduction diet and/or programs
- •Use of medication and supplementation with other carotenoids reasonable expected to impact on primary outcome (e.g. drug treatment for hyperlipidemia)
- •A history of drug abuse
- •Current smoker or excessive alcohol intake (>4 standard drinks per day)
- •Subject has a known allergy or sensitivity to BCX or any ingredients of the study products provided
结局指标
主要结局
Change in plasma concentration of BCX over 8 weeks
时间窗: Baseline, Week 2, Week 4, Week 8
Fasting plasma carotenoids concentrations
次要结局
- Height measurement(Baseline)
- Change in Pittsburgh Sleep Quality Index (PSQI) scores(Baseline, Week 8)
- Change in Body Mass Index (BMI)(Baseline, Week 8)
- Change in waist circumference(Baseline, Week 8)
- Change in State-Trait Anxiety Inventory (STAI) scores(Baseline, Week 8)
- Change in gut microbiota composition(Baseline, Week 8)
- Change in sleep/wake time(Baseline, Week 8)
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire (QLES) scores(Baseline, Week 8)
- Change in body composition - Total body fat(Baseline, Week 8)
- Changes in General Health Questionnaire (GHQ-12) scores(Baseline, Week 8)
- Change in Satisfaction with Life Scale (SLS) scores(Baseline, Week 8)
- Change in weight(Baseline, Week 8)
- Change in Perceived Stress Scale (PSS) scores(Baseline, Week 8)
- Change in Depression Anxiety Stress Scales (DASS) scores(Baseline, Week 2, Week 4, Week 8)
- Change in physical activity(Baseline, Week 8)
研究者
Karen Tan Mei Ling
Research Clinician
Institute for Human Development and Potential (IHDP), Singapore