A Comparison Between Different Approaches to Increase Fruit and Vegetable Intake and Influence Markers of Metabolic Health in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of daily fruit and vegetable portions (from dietary recalls)
研究概览
简要总结
This experimental study aims to evaluate the effects of different strategies for increasing fruit and vegetable intake and to see how these interventions influence markers of health in people aged 18-65 who currently consume fewer than 2 portions of fruit and vegetables a day.
The main questions it aims to answer are:
- How does 5-a-day advice, with and without the inclusion of fruit juice, impact fruit and vegetable intake over a four-week period?
- What are the acceptability and perceived ease of increasing fruit and vegetable intake with and without the inclusion of fruit juice in 5-a-day recommendations?
- What are the effects of increasing fruit and vegetable intake with and without fruit juice on markers of metabolic health?
Researchers will answer these questions by comparing results from three groups of participants. All participants will provide a pre- and post-intervention blood sample, complete various questionnaires, and follow a four-week intervention that comprises educational material and a weekly £10 voucher. Over the course of the four weeks, they will report what they ate in a day on four different days.
The groups differ in the educational materials provided and where they can spend their voucher:
- Group 1 (Control) - information on the importance of including an experimental control in research and a weekly voucher to spend at a retailer of their choice,
- Group 2 (F&V) - information on 5-a-day advice (excluding fruit juice) and a weekly voucher to spend in a supermarket on F&V, and
- Group 3 (F&V + Juice) - information on 5-a-day advice (including fruit juice) and a weekly voucher to spend in a supermarket on F&V.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Aged 18 - 65 years
- •Currently consuming ≤2 portions of fruit and vegetables per day
排除标准
- •Using high-dose vitamins, minerals or dietary supplements that could interfere with biomarker assessment of fruit and vegetable consumption
- •Have a food sensitivity, allergy or other dietary restriction (e.g., following a weight loss diet) that would limit the ability to take part in the study
- •Have a medical condition (e.g., diabetes or gastrointestinal disorders) that would limit the ability to take part in the study
- •Currently pregnant or lactating
研究组 & 干预措施
Group 1 (Control)
Participants will be asked to maintain their habitual diet throughout the intervention. They will be provided with a brief document outlining the importance of a control group in research studies to maximise compliance. They will also receive £10/week vouchers during the intervention period and a further £60 on completion of the study to replicate voucher provision in the two intervention groups. Mimicking the voucher provision structure of the intervention groups will help to minimise participant drop out and will avoid any bias associated with differential financial remuneration between groups.
干预措施: Educational information (Control) (Behavioral)
Group 2 (Whole F&V)
Participants will be provided with educational material to increase their fruit and vegetable intake to meet 5-a-day guidelines via exclusive intake of whole fruits/vegetables . They will receive £10/week supermarket vouchers during the intervention period to support fruit/vegetable purchase. They will receive a further £60 on completion of the study.
干预措施: Educational information (Increasing F&V intake) (Behavioral)
Group 3 (Whole F&V + Juice)
Participants will be provided with educational material to increase fruit and vegetable intake to meet 5-a-day guidelines, with recommendations to consume one portion per day via fruit juice/smoothies. Participants will receive the same financial support as group 2.
干预措施: Educational information (Increasing F&V intake + Juice) (Behavioral)
结局指标
主要结局
Number of daily fruit and vegetable portions (from dietary recalls)
时间窗: 4 weeks
The number of daily portions of fruit and vegetables consumed (including fruit juice in group 3) will be determined by 4 x 24-hour dietary recalls using the validated dietary recall software Intake24 (Foster et al., 2019).
次要结局
- Number of daily fruit and vegetable portions (from brief screening tool)(4 weeks)
- Concentration of serum carotenoids (zeaxanthin)(4 weeks)
- Concentration of serum carotenoids (beta-cryptoxanthin)(4 weeks)
- Concentration of serum carotenoids (lycopene)(4 weeks)
- Concentration of serum carotenoids (alpha-carotene)(4 weeks)
- Concentration of metabolic health markers(4 weeks)
- Change in stool frequency(4 weeks)
- Change in stool consistency(4 weeks)
- Change in bloating frequency(4 weeks)
- Assessment of intervention acceptability(4 weeks)
- Concentration of plasma ascorbic acid(4 weeks)
- Concentration of serum carotenoids (lutein)(4 weeks)
- Concentration of serum carotenoids (beta-carotene)(4 weeks)
- Measure of depression symptom severity (PHQ-9)(4 weeks)
- Measure of anxiety symptom severity (GAD-7)(4 weeks)
- Total number of gut symptoms (score)(4 weeks)
- Change in flatulence symptoms(4 weeks)
研究者
Courtney Neal
Research Assistant
Newcastle University