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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014