Antioxidant Capacity and Vitamin A Profile in Young Adults Who Consume a Snack Bar Made From Tropical Fruits Treated With UV-C

NCT ID: NCT03520725

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-04-30

Brief Summary

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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

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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.

Conditions

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Nutritional and Metabolic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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No Intervention

This group did not have an intervention

Group Type EXPERIMENTAL

No Intervention

Intervention Type OTHER

This gruop did not have an intervention

Intervention pineapple

Daily consumption of 30 g of pineapple snack bar for 4 weeks.

Group Type EXPERIMENTAL

Pineapple snack bar

Intervention Type DIETARY_SUPPLEMENT

30 g daily of pineapple snack bar

Intervention mango

Daily consumption of 30 g of mango snack bar for 4 weeks.

Group Type EXPERIMENTAL

Mango snack bar

Intervention Type DIETARY_SUPPLEMENT

30 g daily of mango snack bar

Interventions

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No Intervention

This gruop did not have an intervention

Intervention Type OTHER

Pineapple snack bar

30 g daily of pineapple snack bar

Intervention Type DIETARY_SUPPLEMENT

Mango snack bar

30 g daily of mango snack bar

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Sonora

OTHER

Sponsor Role collaborator

Centro de Investigación en Alimentación y Desarrollo A.C.

OTHER

Sponsor Role lead

Responsible Party

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Humberto Francisco Astiazaran Garcia, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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HFAG001

Identifier Type: -

Identifier Source: org_study_id

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