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

Primary Purpose

Nutritional and Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
No Intervention
Pineapple snack bar
Mango snack bar
Sponsored by
Centro de Investigación en Alimentación y Desarrollo A.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nutritional and Metabolic Disease focused on measuring antioxidant capacity

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    No Intervention

    Intervention pineapple

    Intervention mango

    Arm Description

    This group did not have an intervention

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

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

    Outcomes

    Primary Outcome Measures

    Change Oxygen Radical Absorbance Capacity Assay (Antioxidant Capacity)
    From baseline and thirty days post treatment
    Change Trolox Equivalent Antioxidant Capacity (Antioxidant Capacity)
    From baseline and thirty days post treatment
    Change Serum Retinol Determination
    From baseline and thirty days post treatment
    Change Serum pro-VA carotenoids
    From baseline and thirty days post treatment

    Secondary Outcome Measures

    Change Serum total polyphenols determination
    From baseline and thirty days post treatment
    Change Serum cholesterol determination
    From baseline and thirty days post treatment
    Change Serum Triacylglycerides determination
    From baseline and thirty days post treatment
    Change Serum high density lipoprotein cholesterol
    From baseline and thirty days post treatment
    Change Body Mass Index
    From baseline and thirty days post treatment
    Change Body composition by fat-free mass index
    From baseline and thirty days post treatment
    Change Body composition by fat mass index
    From baseline and thirty days post treatment
    24-hour dietary recall
    From baseline and thirty days post treatment

    Full Information

    First Posted
    February 23, 2018
    Last Updated
    April 27, 2018
    Sponsor
    Centro de Investigación en Alimentación y Desarrollo A.C.
    Collaborators
    Universidad de Sonora
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03520725
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    April 2017 (Actual)
    Study Completion Date
    April 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centro de Investigación en Alimentación y Desarrollo A.C.
    Collaborators
    Universidad de Sonora

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nutritional and Metabolic Disease
    Keywords
    antioxidant capacity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    No Intervention
    Arm Type
    Experimental
    Arm Description
    This group did not have an intervention
    Arm Title
    Intervention pineapple
    Arm Type
    Experimental
    Arm Description
    Daily consumption of 30 g of pineapple snack bar for 4 weeks.
    Arm Title
    Intervention mango
    Arm Type
    Experimental
    Arm Description
    Daily consumption of 30 g of mango snack bar for 4 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    No Intervention
    Intervention Description
    This gruop did not have an intervention
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Pineapple snack bar
    Intervention Description
    30 g daily of pineapple snack bar
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Mango snack bar
    Intervention Description
    30 g daily of mango snack bar
    Primary Outcome Measure Information:
    Title
    Change Oxygen Radical Absorbance Capacity Assay (Antioxidant Capacity)
    Description
    From baseline and thirty days post treatment
    Time Frame
    Change from baseline at thirty days
    Title
    Change Trolox Equivalent Antioxidant Capacity (Antioxidant Capacity)
    Description
    From baseline and thirty days post treatment
    Time Frame
    Change from baseline at thirty days
    Title
    Change Serum Retinol Determination
    Description
    From baseline and thirty days post treatment
    Time Frame
    Change from baseline at thirty days
    Title
    Change Serum pro-VA carotenoids
    Description
    From baseline and thirty days post treatment
    Time Frame
    Change from baseline at thirty days
    Secondary Outcome Measure Information:
    Title
    Change Serum total polyphenols determination
    Description
    From baseline and thirty days post treatment
    Time Frame
    Change from baseline at thirty days
    Title
    Change Serum cholesterol determination
    Description
    From baseline and thirty days post treatment
    Time Frame
    Change from baseline at thirty days
    Title
    Change Serum Triacylglycerides determination
    Description
    From baseline and thirty days post treatment
    Time Frame
    Change from baseline at thirty days
    Title
    Change Serum high density lipoprotein cholesterol
    Description
    From baseline and thirty days post treatment
    Time Frame
    Change from baseline at thirty days
    Title
    Change Body Mass Index
    Description
    From baseline and thirty days post treatment
    Time Frame
    Change from baseline at thirty days
    Title
    Change Body composition by fat-free mass index
    Description
    From baseline and thirty days post treatment
    Time Frame
    Change from baseline at thirty days
    Title
    Change Body composition by fat mass index
    Description
    From baseline and thirty days post treatment
    Time Frame
    Change from baseline at thirty days
    Title
    24-hour dietary recall
    Description
    From baseline and thirty days post treatment
    Time Frame
    Baseline and thirty days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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.

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

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