Prestudy: Lifestyle and Cardiovascular Disease

NCT ID: NCT00592397

Last Updated: 2017-01-30

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

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-04-30

Brief Summary

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The purpose of this pilot study is to optimize conditions for a planned human intervention study focusing on how diet predispose for, and influence, lifestyle disease development and its consequence in cardiovascular disease development.

Detailed Description

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Common for many of the risk factors of lifestyle diseases is that they are induced by improper diet. Recent research has shown that especially total amount and composition of the macro nutrients, protein, carbohydrate and fats, is important.

A time course experiment has been performed where 5 subjects underwent a diet intervention for four weeks with a controlled, balanced macro nutrient energy content of every meal. The sampling time points were 0, 1, 2, 7, 14 and 28 days. The goals were to determine optimal length of intervention with stabilization of gene expression to occur and compare blood and subcutaneous abdominal fat tissue as source of biological material for RNA for DNA microarray analysis. Microarray analysis were performed on 3 of the 5 subjects.

Conditions

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Obesity Diabetes Mellitus Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

All participants underwent the same dietary intervention

Group Type EXPERIMENTAL

Balanced macronutrient diet intervention

Intervention Type OTHER

Isocaloric dietary changes from typically Western diet to balanced macronutrient composition.

Interventions

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Balanced macronutrient diet intervention

Isocaloric dietary changes from typically Western diet to balanced macronutrient composition.

Intervention Type OTHER

Other Intervention Names

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Microarray study of diet intervention

Eligibility Criteria

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Inclusion Criteria

* healthy males, BMI\>30

Exclusion Criteria

* known chronic disease or in need of any medical treatment
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

FUGE Mid-Norway

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Berit Johansen, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Norwegian University of Science and Technology

Trondheim, Mid-Norway, Norway

Site Status

Countries

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Norway

References

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Brattbakk HR, Arbo I, Aagaard S, Lindseth I, de Soysa AK, Langaas M, Kulseng B, Lindberg F, Johansen B. Balanced caloric macronutrient composition downregulates immunological gene expression in human blood cells-adipose tissue diverges. OMICS. 2013 Jan;17(1):41-52. doi: 10.1089/omi.2010.0124. Epub 2011 Jun 16.

Reference Type RESULT
PMID: 21679058 (View on PubMed)

Other Identifiers

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13714

Identifier Type: OTHER

Identifier Source: secondary_id

REK 4.2005.2187

Identifier Type: -

Identifier Source: org_study_id

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