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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752764
• Other study ID #: FDS-DRS-0573
• Status: Completed
• Phase: N/A
• First received: December 14, 2012
• Last updated: January 27, 2014
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Other:
• Test product: Salad with a high dosage fat

• Control product: Salad with low dosage fat

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No