Antioxidant Capacity and Vitamin A Profile in Young Adults Who Consume a Snack Bar Made From Tropical Fruits Treated With UV-C.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Change Oxygen Radical Absorbance Capacity Assay (Antioxidant Capacity)
研究概览
简要总结
The objective of the present study was to evaluate the impact of a snack bar on some health indicators associated with diet (plasma antioxidant capacity, lipid profile, vitamin A profile (retinol and carotenoids)) and on the nutritional status (impact on energy and nutrients consumed) in a group of upper level students.
详细描述
A blind randomized controlled clinical study of healthy adults, which was carried out with the approval of the ethics committee of the Centro de Investigación en Alimentación y Desarrollo, A.C. (CIAD, A.C.) with registration CE/001/2017. The intervention was carried out in a public university in Mexico from January to April 2017. Each subject signed an informed consent form. This study lasted 30 days (4 weeks), where each participant consumed daily a snack bar irradiated with UV-C. The participants were personally interviewed by the research team with a structured selection questionnaire. Thirty subjects who met the inclusion criteria were recruited, 15 of them men and 15 women. Through a simple randomization process, the participants were assigned in 3 groups of 10 people each with 5 women and 5 men, subsequently treatments (without treatment, pineapple snack bar, or mango snack bar) were randomly assigned. The outcomes between groups were analyzed with one way ANOVA, with a P-value of 0.05 or less when there was statistical significance, using statistical software. The participants, and the laboratory technicians were blinded to the treatment assignments until the conclusion of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young adults of 18 years of age or older,
- •Healthy in appearance
排除标准
- •People in current medical treatment
- •Used antibiotics in past 15 days
- •Have presented infectious symptoms on previous days
- •Narcotic consumers
- •Women in use of hormonal treatment
- •Contraceptives or pregnancy
研究组 & 干预措施
Intervention pineapple
Daily consumption of 30 g of pineapple snack bar for 4 weeks.
干预措施: Pineapple snack bar (Dietary Supplement)
Intervention mango
Daily consumption of 30 g of mango snack bar for 4 weeks.
干预措施: Mango snack bar (Dietary Supplement)
No Intervention
This group did not have an intervention
干预措施: No Intervention (Other)
结局指标
主要结局
Change Oxygen Radical Absorbance Capacity Assay (Antioxidant Capacity)
时间窗: Change from baseline at thirty days
From baseline and thirty days post treatment
Change Trolox Equivalent Antioxidant Capacity (Antioxidant Capacity)
时间窗: Change from baseline at thirty days
From baseline and thirty days post treatment
Change Serum Retinol Determination
时间窗: Change from baseline at thirty days
From baseline and thirty days post treatment
Change Serum pro-VA carotenoids
时间窗: Change from baseline at thirty days
From baseline and thirty days post treatment
次要结局
- Change Body composition by fat-free mass index(Change from baseline at thirty days)
- Change Serum high density lipoprotein cholesterol(Change from baseline at thirty days)
- Change Body composition by fat mass index(Change from baseline at thirty days)
- Change Serum total polyphenols determination(Change from baseline at thirty days)
- Change Serum cholesterol determination(Change from baseline at thirty days)
- Change Serum Triacylglycerides determination(Change from baseline at thirty days)
- Change Body Mass Index(Change from baseline at thirty days)
- 24-hour dietary recall(Baseline and thirty days)
研究者
Humberto Francisco Astiazaran Garcia, PhD
Principal Investigator
Centro de Investigación en Alimentación y Desarrollo A.C.