Healthy SubjectsNCT01752764
Assessment of the Relative Increase in Bioavailability of (Non-) Nutrients From a Mixed Salad by Adding Fat Containing Dressing
A study testing Test product: Salad with a high dosage fat in people with Healthy Subjects, run by Unilever R&D at 1 site in Brazil.
Trial summary
The hypothesis will be tested that fat can also increase absorption of (non)-nutrients from a salad. Therefore we designed the current study to show an increase in relative absorption (bioavailability) of (non-) nutrients from a mixed salad by adding fat containing dressing. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Test product: Salad with a high dosage fat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to Dec 2013
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Main inclusion Criteria:
- Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2.
- Apparently healthy: no medical conditions, no use of prescribed or over the counter drugs, which might affect study measurements (as judged by study physician)
- Haemoglobin within normal reference range as judged by the study physician.
- Total cholesterol, LDL cholesterol, HDL cholesterol and fasting triglycerides within the normal reference range, as judged by the study physician.
Main exclusion Criteria:
- Reported use of any medically- or self-prescribed diet at the moment of screening, or the intention to use any kind of diet in the period between screening and the end of the study.
- Reported weight loss or gain ≥ 10 % of bodyweight during a period of six months before screening.
- A known food allergy or intolerance.
- A dislike to the foods supplied during the study.
- Use of vitamins or supplements enriched with carotenoid and/or vitamin A and/of vitamin K.
- Known hypothyroidism or hyperthyroidism.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo / Incor HC FM USP
São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 44, SP - 05403-000
About this study
The hypothesis will be tested that fat can also increase absorption of (non)-nutrients from a salad. Therefore we designed the current study to show an increase in relative absorption (bioavailability) of (non-) nutrients from a mixed salad by adding fat containing dressing.
- Conditions
- Healthy Subjects
- Being tested
- Test product: Salad with a high dosage fat, Control product: Salad with low dosage fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test product: Salad with a high dosage fatOther
Control product: Salad with low dosage fatOther
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Test product: Salad with high dosage fat Receives: Other: Test product: Salad with a high dosage fat; Other: Control product: Salad with low dosage fat |
| Control product | Other | Control product: Salad with low dosage fat Receives: Other: Test product: Salad with a high dosage fat; Other: Control product: Salad with low dosage fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC in nmol/l*h) of (non) nutrients
Area under the curve (AUC in nmol/l*h) of (non) nutrients. The AUCs are constructed from (non-) nutrient levels measured in plasma chylomicrons at the selected time-points. The size of the areas under the curves will be compared between the test and control dressing.
Measured: July 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Raul C. Maranhão, M.D, Ph.D., Principal investigator, Head Professor of Clinical Biochemistry, Faculty of Pharmaceutical Sciences Director, Lipid Metabolism Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752764
- Sponsor's protocol ID
- FDS-DRS-0573
- Status last verified
- Jan 2014
- First submitted
- 14 Dec 2012
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relative Increase in Bioavailability of (Non-) Nutrients From a Mixed Salad by Adding Fat Containing Dressing
- ClinicalTrials.gov ID
- NCT01752764
- Acronym / sponsor ID
- FDS-DRS-0573
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Dec 2012 (estimated)
- 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 hypothesis will be tested that fat can also increase absorption of (non)-nutrients from a salad. Therefore we designed the current study to show an increase in relative absorption (bioavailability) of (non-) nutrients from a mixed salad by adding fat containing dressing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Other: Test product: Salad with a high dosage fat, Other: Control product: Salad with low dosage fatTest product: Salad with high dosage fat |
| Control product | Other | Other: Test product: Salad with a high dosage fat, Other: Control product: Salad with low dosage fatControl product: Salad with low dosage fat |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Test product: Salad with a high dosage fat | Other | Control product, Test product |
| Control product: Salad with low dosage fat | Other | Control product, Test product |
Primary outcome
Area under the curve (AUC in nmol/l*h) of (non) nutrients
Time frame: July 2013
Area under the curve (AUC in nmol/l*h) of (non) nutrients. The AUCs are constructed from (non-) nutrient levels measured in plasma chylomicrons at the selected time-points. The size of the areas under the curves will be compared between the test and control dressing.
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 28 Jan 2014.
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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.
Dr. Raul C. Maranhão, M.D, Ph.D. principal investigator
Head Professor of Clinical Biochemistry, Faculty of Pharmaceutical Sciences Director, Lipid Metabolism Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product: Salad with a high dosage fat in people with Healthy Subjects, run by Unilever R&D at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Area under the curve (AUC in nmol/l*h) of (non) nutrients (time frame: July 2013). 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 28 Jan 2014.