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OpenTrials
Completed

NCT Number: NCT01752764

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.

Completed

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test product: Salad with a high dosage fat

Other

Control product: Salad with low dosage fat

Other

Primary outcomes

  1. Area under the curve (AUC in nmol/l*h) of (non) nutrients

    Time frame: July 2013

    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.

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 19, 2012
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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