Plasma Lycopene Concentration as a Dietary Compliance Biomarker - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To measure lycopene concentration after a single dose of dietary lycopene.
研究概览
简要总结
Rationale: To determine the plasma lycopene concentration before and after an oral intake of lycopene in order to use this measurement as a life style compliance marker.
Objective: Primary objective: to determine if a plasma lycopene concentration can serve as a response parameter after a single dose of dietary lycopene.
Study design: Cross-over interventional pilot study.
Study population: Ten male healthy volunteers 18-75 years. Intervention: Oral food supplement tablet 40 mg lycopene once, versus oral soup of cooked tomatoes equivalent to 40 mg lycopene content. In addition, the participants' habitual diet and actual food intake during the intervention will be measured using a food frequency questionnaire and a food diary.
Main study parameters/endpoints: Variation of plasma lycopene 1 hour before, and 1,3,6,12,24,48,72 hours after intervention.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Eight blood samples of 6 ml full venous blood obtained by vena puncture per intervention per individual, 2 times in a cross-over pilot study, in which interventions are 3 weeks apart (so 2 x 8 samples in 10 volunteers). Risk of vena puncture is negligible, idemque the burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18-75 yrs old.
排除标准
- •Allergic for tomatoes;
- •Any gastrointestinal disorder within 3 months prior to the intervention;
- •Recent medication or supplement use;
- •Recent substantial change in weight;
- •Adherence to a specific diet ( for example the Moorman-diet);
- •Using recreational drugs more than once a month;
- •Smoking and excessive alcohol consumption (>10 standardized glasses a week).
- •Risk of a dependency situation with the researchers.
研究组 & 干预措施
Group A - supplement, tomato soup
Group A will take 40 mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract) first. After a wash-out period, group A will continue and take 250ml of tomato soup (matching with 40mg lycopene) with 20ml olive oil.
干预措施: Supplement (Dietary Supplement)
Group A - supplement, tomato soup
Group A will take 40 mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract) first. After a wash-out period, group A will continue and take 250ml of tomato soup (matching with 40mg lycopene) with 20ml olive oil.
干预措施: Tomato soup (Other)
Group B - tomato soup, supplement
Group B will take 250 ml of tomato soup (matching with 40 mg lycopene) with 20 ml olive oil first. After a wash-out period, group B will continue and take 40mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract).
干预措施: Supplement (Dietary Supplement)
Group B - tomato soup, supplement
Group B will take 250 ml of tomato soup (matching with 40 mg lycopene) with 20 ml olive oil first. After a wash-out period, group B will continue and take 40mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract).
干预措施: Tomato soup (Other)
结局指标
主要结局
To measure lycopene concentration after a single dose of dietary lycopene.
时间窗: From enrollment until 72 hours after, wash out period of 3 weeks, then again start until 72 hours later.
次要结局
- To measure prior food consumption using a daily food questionnaire.(One week before the dietary intervention a daily food questionnaire will be completed.)
- To measure lycopene concentration after taking a food supplement tablet lycopene of 40mg of lycopene.(Start intervention until 72 hours later, wash-out period, start intervention until 72 hours later.)
研究者
Lionne Venderbos
Assistant Professor
Erasmus Medical Center