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:
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01752764
First received: December 14, 2012
Last updated: January 27, 2014
Last verified: January 2014
  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.


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

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

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

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: January 27, 2014
Health Authority: Brazil: Ministry of Health

ClinicalTrials.gov processed this record on April 17, 2014