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

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

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.

Study Overview

• Status: Completed
• Conditions: Nutritional and Metabolic Disease
• Intervention / Treatment: Other: No Intervention; Dietary supplement: Pineapple snack bar; Dietary supplement: Mango snack bar

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No Intervention; This group did not have an intervention	Other: No Intervention; This gruop did not have an intervention
Experimental: Intervention pineapple; Daily consumption of 30 g of pineapple snack bar for 4 weeks.	Dietary supplement: Pineapple snack bar; 30 g daily of pineapple snack bar
Experimental: Intervention mango; Daily consumption of 30 g of mango snack bar for 4 weeks.	Dietary supplement: Mango snack bar; 30 g daily of mango snack bar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Oxygen Radical Absorbance Capacity Assay (Antioxidant Capacity)	From baseline and thirty days post treatment	Change from baseline at thirty days
Change Trolox Equivalent Antioxidant Capacity (Antioxidant Capacity)	From baseline and thirty days post treatment	Change from baseline at thirty days
Change Serum Retinol Determination	From baseline and thirty days post treatment	Change from baseline at thirty days
Change Serum pro-VA carotenoids	From baseline and thirty days post treatment	Change from baseline at thirty days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Serum total polyphenols determination	From baseline and thirty days post treatment	Change from baseline at thirty days
Change Serum cholesterol determination	From baseline and thirty days post treatment	Change from baseline at thirty days
Change Serum Triacylglycerides determination	From baseline and thirty days post treatment	Change from baseline at thirty days
Change Serum high density lipoprotein cholesterol	From baseline and thirty days post treatment	Change from baseline at thirty days
Change Body Mass Index	From baseline and thirty days post treatment	Change from baseline at thirty days
Change Body composition by fat-free mass index	From baseline and thirty days post treatment	Change from baseline at thirty days
Change Body composition by fat mass index	From baseline and thirty days post treatment	Change from baseline at thirty days
24-hour dietary recall	From baseline and thirty days post treatment	Baseline and thirty days

Collaborators and Investigators

• Sponsor: Centro de Investigación en Alimentación y Desarrollo A.C.
• Collaborators: Universidad de Sonora

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: antioxidant capacity
• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: HFAG001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data base will not be shared, each collaborator will participate verifying the handling of the samples and the process of analysing the results in a blinded manner.