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Completed

NCT Number: NCT03520725

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.

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Key information

Conditions

Nutritional and Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

This gruop did not have an intervention

Pineapple snack bar

Dietary Supplement

30 g daily of pineapple snack bar

Mango snack bar

Dietary Supplement

30 g daily of mango snack bar

Primary outcomes

  1. Change Oxygen Radical Absorbance Capacity Assay (Antioxidant Capacity)

    Time frame: Change from baseline at thirty days

    From baseline and thirty days post treatment

  2. Change Trolox Equivalent Antioxidant Capacity (Antioxidant Capacity)

    Time frame: Change from baseline at thirty days

    From baseline and thirty days post treatment

  3. Change Serum Retinol Determination

    Time frame: Change from baseline at thirty days

    From baseline and thirty days post treatment

  4. Change Serum pro-VA carotenoids

    Time frame: Change from baseline at thirty days

    From baseline and thirty days post treatment

Secondary outcomes

  1. Change Serum total polyphenols determination

    Time frame: Change from baseline at thirty days

    From baseline and thirty days post treatment

  2. Change Serum cholesterol determination

    Time frame: Change from baseline at thirty days

    From baseline and thirty days post treatment

  3. Change Serum Triacylglycerides determination

    Time frame: Change from baseline at thirty days

    From baseline and thirty days post treatment

  4. Change Serum high density lipoprotein cholesterol

    Time frame: Change from baseline at thirty days

    From baseline and thirty days post treatment

  5. Change Body Mass Index

    Time frame: Change from baseline at thirty days

    From baseline and thirty days post treatment

  6. Change Body composition by fat-free mass index

    Time frame: Change from baseline at thirty days

    From baseline and thirty days post treatment

  7. Change Body composition by fat mass index

    Time frame: Change from baseline at thirty days

    From baseline and thirty days post treatment

  8. 24-hour dietary recall

    Time frame: Baseline and thirty days

    From baseline and thirty days post treatment

Sponsors and collaborators

Lead sponsor

Centro de Investigación en Alimentación y Desarrollo A.C.

Other

Collaborators

  • Universidad de Sonora

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 11, 2018
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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