NCT03520725

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
Last Updated

May 11, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

February 23, 2018

Last Update Submit

April 27, 2018

Conditions

Keywords

antioxidant capacity

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (8)

  • Change Serum total polyphenols determination

    Change from baseline at thirty days

  • Change Serum cholesterol determination

    Change from baseline at thirty days

  • Change Serum Triacylglycerides determination

    Change from baseline at thirty days

  • Change Serum high density lipoprotein cholesterol

    Change from baseline at thirty days

  • Change Body Mass Index

    Change from baseline at thirty days

  • +3 more secondary outcomes

Study Arms (3)

No Intervention

EXPERIMENTAL

This group did not have an intervention

Other: No Intervention

Intervention pineapple

EXPERIMENTAL

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

Dietary Supplement: Pineapple snack bar

Intervention mango

EXPERIMENTAL

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

Dietary Supplement: Mango snack bar

Interventions

This gruop did not have an intervention

No Intervention
Pineapple snack barDIETARY_SUPPLEMENT

30 g daily of pineapple snack bar

Intervention pineapple
Mango snack barDIETARY_SUPPLEMENT

30 g daily of mango snack bar

Intervention mango

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young adults of 18 years of age or older,
  • Healthy in appearance

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2018

First Posted

May 11, 2018

Study Start

December 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

May 11, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

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.