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Assessment of the Relative Increase in Bioavailability of (Non-) Nutrients From a Mixed Salad by Adding Fat Containing Dressing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01752764
First Posted: December 19, 2012
Last Update Posted: January 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Unilever R&D
  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
Intervention Model: Crossover Assignment
Masking: Single (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 ]
    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.


Enrollment: 12
Study Start Date: April 2013
Study Completion Date: December 2013
Primary Completion Date: December 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752764


Locations
Brazil
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, 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

Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01752764     History of Changes
Other Study ID Numbers: FDS-DRS-0573
First Submitted: December 14, 2012
First Posted: December 19, 2012
Last Update Posted: January 28, 2014
Last Verified: January 2014