Clinical trial NCT03520725: Antioxidant Capacity and Vitamin A Profile in Young Adults Who Consume a Snack Bar Made From Tropical Fruits Treated With UV-C
Official title: Antioxidant Capacity and Vitamin A Profile in Young Adults Who Consume a Snack Bar Made From Tropical Fruits Treated With UV-C.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional and Metabolic Disease
Keywords: antioxidant capacity
Lead sponsor: Centro de Investigación en Alimentación y Desarrollo A.C.
Sponsor class: OTHER
Collaborators: name: Universidad de Sonora
First posted: 2018-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Young adults of 18 years of age or older,
* Healthy in appearance

Exclusion Criteria:

* People in current medical treatment
* Used antibiotics in past 15 days
* Have presented infectious symptoms on previous days
* Smokers
* Narcotic consumers
* Women in use of hormonal treatment
* Contraceptives or pregnancy

Primary outcomes:
measure: Change Oxygen Radical Absorbance Capacity Assay (Antioxidant Capacity)
timeFrame: Change from baseline at thirty days
measure: Change Trolox Equivalent Antioxidant Capacity (Antioxidant Capacity)
timeFrame: Change from baseline at thirty days
measure: Change Serum Retinol Determination
timeFrame: Change from baseline at thirty days
measure: Change Serum pro-VA carotenoids
timeFrame: Change from baseline at thirty days
Secondary outcomes:
measure: Change Serum total polyphenols determination
timeFrame: Change from baseline at thirty days
measure: Change Serum cholesterol determination
timeFrame: Change from baseline at thirty days
measure: Change Serum Triacylglycerides determination
timeFrame: Change from baseline at thirty days
measure: Change Serum high density lipoprotein cholesterol
timeFrame: Change from baseline at thirty days
measure: Change Body Mass Index
timeFrame: Change from baseline at thirty days
measure: Change Body composition by fat-free mass index
timeFrame: Change from baseline at thirty days
measure: Change Body composition by fat mass index
timeFrame: Change from baseline at thirty days
measure: 24-hour dietary recall
timeFrame: Baseline and thirty days
Other outcomes:
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