Does a Nutritional Supplement Increase Vitality, Energy and Perceived Well Being?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in score on the Short-Form 36 (SF-36)
研究概览
简要总结
Factors Group is a producer of nutritional supplements. This study aims to determine whether one of their products improves the energy and sense of well-being in individuals who consume it. Interested subjects will complete a 1 week lead-in phase where they will be asked to consume a placebo daily to see if they are a good fit for the study. After the lead-in phase, subjects will be randomized to take either All Greens or a different placebo for 12 weeks. The investigators expect All Greens to have better results than the placebo, but subjects will not know which supplement they are taking. The primary outcome is a score on a questionnaire of well being.
详细描述
PURPOSE To conduct a study to determine the potential benefits of All Greens.
HYPOTHESIS Our primary hypothesis is that a greater proportion of participants on All Greens will score higher on the subjective scores of vitality and energy, as measured by our validated survey, than those consuming the control formulation.
JUSTIFICATION All Greens is a mixture of organic alfalfa powder, barley, wheat grass juice powder, lycopene, cranberry juice extract, rosehips, grapeseed phytosomes, soya extract, Acidophilus, bromelain, apple pectin, and other ingredients. All Greens is a well-balanced phytonutrient formula that nourishes, energizes, cleanses and acts as a whole body tonic. Recently, Boon et al (2004) have published results demonstrating some clinical benefits of consuming Greens+, a product similar to All Greens. After 12 weeks, women randomized to consume Greens+ scored marginally higher on subjective scores on Vitality and significantly higher on Energy than those consuming a placebo group (Boon, 2004). However, limitations of this study such as incomplete blinding and a high drop-out rate limit the veracity of the findings.
OBJECTIVES To determine if 12 weeks of consumption of All Greens increases vitality, energy, and perception of well-being compared to consumption of a placebo in adult women and men (18-45 y).
RESEARCH METHOD The investigators aim to recruit 120 people (18-45 y) through advertisements and word of mouth. In a lead-in phase, subjects will be asked to consume an 'initiation drink' daily for a week. The purpose of this is to identify those subjects who are unlikely to complete the study so they can be excluded before randomization, in order to minimize the dropout rate. The lead-in product will be composed primarily of rice flour, with other ingredients added to make it comparable to the All Greens and control formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Not taking any other nutritional supplement (including fish oils, vitamins...) or be willing to discontinue use for duration of study
排除标准
- •Medical conditions such as diabetes, asthma, cancer, cardiovascular disease, high blood pressure, celiac disease, a history of kidney stones or psychiatric illness.
- •Currently taking antidepressants, anticoagulant or other medications that may interact with the nutritional supplement.
- •Unable to provide informed consent
- •Women who are pregnant or breastfeeding
结局指标
主要结局
Change in score on the Short-Form 36 (SF-36)
时间窗: Baseline and Study End (12 weeks after randomization)
The Short Form-36 (SF-36) is a validated, multi-purpose, short-form health survey that is a generic measure of health status/quality of life. It provides an overall measure of physical and mental health, as well as eight subscale profiles, of which three were considered to be relevant for this study: general health, vitality, and mental health. The SF-36 is licensed by the company QualityMetric.
次要结局
- Number of participants who report side effects(From enrollment to 13 weeks (study end))
- Number of unused supplement packets(Enrollment to 13 weeks (study end))
- Change in scores on 10 cm Visual Analogue Scales (VAS)(Randomization and 12 weeks (study end))
