Impact of Dairy Products on Postprandial Inflammation

NCT ID: NCT01885416

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-11-30

Brief Summary

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The study will quantitatively evaluate the systemic, postprandial inflammatory and metabolic response to the ingestion of three different meals in obese subjects. The administered meals will differ in the proportion of dairy products. Postprandial response will be monitored during 6 hours after meal consumption.

Detailed Description

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Conditions

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Inflammation Obesity Nutritional Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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high fat meal without dairy products

high fat meal without dairy products

Group Type ACTIVE_COMPARATOR

consumption of high fat test meal without dairy products

Intervention Type OTHER

high fat meal with additional milk

high fat meal with additional milk

Group Type EXPERIMENTAL

consumption of high fat test meal with dairy products

Intervention Type OTHER

dairy product meal

dairy product meal

Group Type EXPERIMENTAL

consumption of test meal based on dairy products

Intervention Type OTHER

Interventions

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consumption of test meal based on dairy products

Intervention Type OTHER

consumption of high fat test meal without dairy products

Intervention Type OTHER

consumption of high fat test meal with dairy products

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* male
* BMI ≥ 20 kg/m2
* age 25-55 y
* informed consent

Exclusion Criteria

* Physiological or psychological diseases
* Allergies to food or intolerance to high-fat meal
* Vegetarians
* Chronic intake of drugs
* Smokers
* Diabetes mellitus Type I and II
* Debilitating kidney diseases
* Debilitating liver diseases
* Clinically established coronary heart diseases
* Ingestion of vitamins or dietary supplements during the course of the study
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

Agroscope Liebefeld-Posieux Research Station ALP

OTHER

Sponsor Role lead

Responsible Party

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Guy Vergeres

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kur Laederach, MD

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Alexandra Schmid

Role: STUDY_DIRECTOR

Agroscope Liebefeld-Posieux ALP

Caroline Buri, MD, PhD

Role: STUDY_DIRECTOR

Insel Gruppe AG, University Hospital Bern

Guy Vergères, PhD

Role: STUDY_DIRECTOR

Agroscope Liebefeld-Posieux ALP

Locations

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University Hospital, Inselspital Berne

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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NUTRICHIP-2

Identifier Type: -

Identifier Source: org_study_id