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

Nutritional and Metabolic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520725
• Other study ID #: HFAG001
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: April 2017

Study information

• Verified date: January 2018
• Source: Centro de Investigación en Alimentación y Desarrollo A.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Disease

Intervention

Other:
• No Intervention
This gruop did not have an intervention

Dietary Supplement:
• Pineapple snack bar
30 g daily of pineapple snack bar
• Mango snack bar
30 g daily of mango snack bar

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centro de Investigación en Alimentación y Desarrollo A.C.	Universidad de Sonora

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Oxygen Radical Absorbance Capacity Assay (Antioxidant Capacity)	From baseline and thirty days post treatment	Change from baseline at thirty days
Primary	Change Trolox Equivalent Antioxidant Capacity (Antioxidant Capacity)	From baseline and thirty days post treatment	Change from baseline at thirty days
Primary	Change Serum Retinol Determination	From baseline and thirty days post treatment	Change from baseline at thirty days
Primary	Change Serum pro-VA carotenoids	From baseline and thirty days post treatment	Change from baseline at thirty days
Secondary	Change Serum total polyphenols determination	From baseline and thirty days post treatment	Change from baseline at thirty days
Secondary	Change Serum cholesterol determination	From baseline and thirty days post treatment	Change from baseline at thirty days
Secondary	Change Serum Triacylglycerides determination	From baseline and thirty days post treatment	Change from baseline at thirty days
Secondary	Change Serum high density lipoprotein cholesterol	From baseline and thirty days post treatment	Change from baseline at thirty days
Secondary	Change Body Mass Index	From baseline and thirty days post treatment	Change from baseline at thirty days
Secondary	Change Body composition by fat-free mass index	From baseline and thirty days post treatment	Change from baseline at thirty days
Secondary	Change Body composition by fat mass index	From baseline and thirty days post treatment	Change from baseline at thirty days
Secondary	24-hour dietary recall	From baseline and thirty days post treatment	Baseline and thirty days