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

NCT01752764 | Completed

• 1 other identifier: FDS-DRS-0573
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test product

EXPERIMENTAL

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

OTHER

Control product: Salad with low dosage fat

Other: Test product: Salad with a high dosage fat; Other: Control product: Salad with low dosage fat

Interventions

Test product: Salad with a high dosage fat OTHER

Control product; Test product

Control product: Salad with low dosage fat OTHER

Control product; Test product

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unilever R&D: lead

Study Sites (1)

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, SP - 05403-000, Brazil

Location

Study Officials

• Dr. Raul C. Maranhão, M.D, Ph.D.

  Head Professor of Clinical Biochemistry, Faculty of Pharmaceutical Sciences Director, Lipid Metabolism Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 19, 2012
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 28, 2014

Record last verified: 2014-01

Locations

BR (1)