Assessment of the Relative Increase in Bioavailability of (Non-) Nutrients From a Mixed Salad by Adding Fat Containing Dressing
This study is not yet open for participant recruitment.
Verified March 2013 by Unilever R&D
Sponsor:
Unilever R&D
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01752764
First received: December 14, 2012
Last updated: March 5, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy Subjects |
Other: Test product: Salad with a high dosage fat Other: Control product: Salad with low dosage fat |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Assessment of the Relative Increase in Bioavailability of (Non-) Nutrients From a Mixed Salad by Adding Fat Containing Dressing |
Further study details as provided by Unilever R&D:
Primary Outcome Measures:
- Area under the curve (AUC in nmol/l*h) of (non) nutrients [ Time Frame: July 2013 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 12 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Test product
Test product: Salad with high dosage fat
|
Other: Test product: Salad with a high dosage fat Other: Control product: Salad with low dosage fat |
|
Control product
Control product: Salad with low dosage fat
|
Other: Test product: Salad with a high dosage fat Other: Control product: Salad with low dosage fat |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752764
Contacts
| Contact: Fernanda Martins, MSc | +55 11 37037072 | Fernanda.O.Martins@unilever.com |
Locations
| Brazil | |
| Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo / Incor HC FM USP | Not yet recruiting |
| São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 44, Brazil, SP - 05403-000 | |
Sponsors and Collaborators
Unilever R&D
Investigators
| Principal Investigator: | Dr. Raul C. Maranhão, M.D, Ph.D. | Head Professor of Clinical Biochemistry, Faculty of Pharmaceutical Sciences Director, Lipid Metabolism Laboratory |
More Information
No publications provided
| Responsible Party: | Unilever R&D |
| ClinicalTrials.gov Identifier: | NCT01752764 History of Changes |
| Other Study ID Numbers: | FDS-DRS-0573 |
| Study First Received: | December 14, 2012 |
| Last Updated: | March 5, 2013 |
| Health Authority: | Brazil: Ministry of Health |
ClinicalTrials.gov processed this record on May 19, 2013