Nutritional and Metabolic DiseaseNCT03520725
Antioxidant Capacity and Vitamin A Profile in Young Adults Who Consume a Snack Bar Made From Tropical Fruits Treated With UV-C
A study testing Pineapple snack bar and Mango snack bar in people with Nutritional and Metabolic Disease, run by Centro de Investigación en Alimentación y Desarrollo A.C..
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional and Metabolic Disease
- What is being tested?
- Pineapple snack bar and Mango snack bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young adults of 18 years of age or older,
- Healthy in appearance
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutritional and Metabolic Disease
- Being tested
- No Intervention, Pineapple snack bar, Mango snack bar
- Keywords
- antioxidant capacity
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This gruop did not have an intervention
Pineapple snack barDietary supplement
30 g daily of pineapple snack bar
Mango snack barDietary supplement
30 g daily of mango snack bar
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | Experimental | This group did not have an intervention Receives: Other: No Intervention |
| Intervention pineapple | Experimental | Daily consumption of 30 g of pineapple snack bar for 4 weeks. Receives: Dietary Supplement: Pineapple snack bar |
| Intervention mango | Experimental | Daily consumption of 30 g of mango snack bar for 4 weeks. Receives: Dietary Supplement: Mango snack bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Oxygen Radical Absorbance Capacity Assay (Antioxidant Capacity)
From baseline and thirty days post treatment
Measured: Change from baseline at thirty days
Change Trolox Equivalent Antioxidant Capacity (Antioxidant Capacity)
From baseline and thirty days post treatment
Measured: Change from baseline at thirty days
Change Serum Retinol Determination
From baseline and thirty days post treatment
Measured: Change from baseline at thirty days
Change Serum pro-VA carotenoids
From baseline and thirty days post treatment
Measured: Change from baseline at thirty days
Secondary outcomes (8)
Change Serum total polyphenols determination
From baseline and thirty days post treatment
Measured: Change from baseline at thirty days
Change Serum cholesterol determination
From baseline and thirty days post treatment
Measured: Change from baseline at thirty days
Change Serum Triacylglycerides determination
From baseline and thirty days post treatment
Measured: Change from baseline at thirty days
Change Serum high density lipoprotein cholesterol
From baseline and thirty days post treatment
Measured: Change from baseline at thirty days
Change Body Mass Index
From baseline and thirty days post treatment
Measured: Change from baseline at thirty days
Change Body composition by fat-free mass index
From baseline and thirty days post treatment
Measured: Change from baseline at thirty days
Change Body composition by fat mass index
From baseline and thirty days post treatment
Measured: Change from baseline at thirty days
24-hour dietary recall
From baseline and thirty days post treatment
Measured: Baseline and thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study startDec 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional and Metabolic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Sonora
- Responsible party
- Principal investigator, Humberto Francisco Astiazaran Garcia, PhD, Centro de Investigación en Alimentación y Desarrollo A.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520725
- Sponsor's protocol ID
- HFAG001
- Status last verified
- Jan 2018
- First submitted
- 23 Feb 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidant Capacity and Vitamin A Profile in Young Adults Who Consume a Snack Bar Made From Tropical Fruits Treated With UV-C.
- ClinicalTrials.gov ID
- NCT03520725
- Acronym / sponsor ID
- HFAG001
- Conditions
- Nutritional and Metabolic Disease
- Keywords
- antioxidant capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.University, hospital or other
- Collaborators
- Universidad de Sonora
- Study start
- Dec 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Intervention | Experimental | Other: No InterventionThis group did not have an intervention |
| Intervention pineapple | Experimental | Dietary Supplement: Pineapple snack barDaily consumption of 30 g of pineapple snack bar for 4 weeks. |
| Intervention mango | Experimental | Dietary Supplement: Mango snack barDaily consumption of 30 g of mango snack bar for 4 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Young adults of 18 years of age or older,
- Healthy in appearance
Key exclusion criteria (7 listed)
- People in current medical treatment
- Used antibiotics in past 15 days
- Have presented infectious symptoms on previous days
- Smokers
- Narcotic consumers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis gruop did not have an intervention | Other | No Intervention |
| Pineapple snack bar30 g daily of pineapple snack bar | Dietary supplement | Intervention pineapple |
| Mango snack bar30 g daily of mango snack bar | Dietary supplement | Intervention mango |
Primary outcome
Change Oxygen Radical Absorbance Capacity Assay (Antioxidant Capacity)
Time frame: Change from baseline at thirty days
From baseline and thirty days post treatment
Change Trolox Equivalent Antioxidant Capacity (Antioxidant Capacity)
Time frame: Change from baseline at thirty days
From baseline and thirty days post treatment
Change Serum Retinol Determination
Time frame: Change from baseline at thirty days
From baseline and thirty days post treatment
Change Serum pro-VA carotenoids
Time frame: Change from baseline at thirty days
From baseline and thirty days post treatment
8 secondary outcomes
Change Serum total polyphenols determination
Time frame: Change from baseline at thirty days
Change Serum cholesterol determination
Time frame: Change from baseline at thirty days
Change Serum Triacylglycerides determination
Time frame: Change from baseline at thirty days
Change Serum high density lipoprotein cholesterol
Time frame: Change from baseline at thirty days
Change Body Mass Index
Time frame: Change from baseline at thirty days
Change Body composition by fat-free mass index
Time frame: Change from baseline at thirty days
Change Body composition by fat mass index
Time frame: Change from baseline at thirty days
24-hour dietary recall
Time frame: Baseline and thirty days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pineapple snack bar and Mango snack bar in people with Nutritional and Metabolic Disease, run by Centro de Investigación en Alimentación y Desarrollo A.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Oxygen Radical Absorbance Capacity Assay (Antioxidant Capacity) (time frame: Change from baseline at thirty days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.