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

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 Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Other: Test product: Salad with a high dosage fat; Other: Control product: Salad with low dosage fat

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Av. Dr. Enéas de Carvalho Aguiar, 44
    • São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 44, Brazil, SP - 05403-000
      • Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo / Incor HC FM USP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	July 2013

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 14, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 19, 2012

Study Record Updates

• Last Update Posted (Estimate): January 28, 2014
• Last Update Submitted That Met QC Criteria: January 27, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: FDS-DRS-0573