Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/09/2014
Date assigned
08/10/2014
Last edited
08/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study investigates the benefits of nutritional unsaturated fats on blood lipids (the fat in your blood) and metabolism in fat tissue (the process of breaking down fat for energy) for people who are overweight. Rapeseed (canola) oil and olive oil are both recommended for a healthy diet because of their high content of unsaturated fats. However, these oils contain different types of unsaturated fats. Here, we want to compare the two and then improve the nutritional recommendations for overweight people.

Who can participate?
Overweight men aged 18-65.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given 50 g of rapeseed (canola) oil to add to their daily food for 4 weeks. Those in group 2 are given 50 g of olive oil to add to their daily food for 4 weeks. At the end of the fourth week early in the morning blood is taken for analysis of lipid levels. Also, we will use a thin needle to take a sample of about 1 gram of fat from under the skin near the belly button under a local anaesthetic. Then participants are given a meal. Blood and a second sample of fat are taken again after four hours of the meal. The samples of fat are then analysed in the laboratory.

What are the possible benefits and risks of participating?
Participants will get information on their blood lipid levels and how overweight they are. Taking a sample of fat may result in a bruise, a small scar or an infection. In the case of developing a bruise, it will disappear completely within weeks. In the case of developing a scar, it will be almost invisible (smaller than 3 millimetres). It is very unlikely that an infection will develop, since this procedure will be performed under sterile conditions.

Where is the study run from?
German Institute of Human Nutrition Potsdam Rehbruecke (Germany).

When is the study starting and how long is it expected to run for?
September 2010 to October 2011.

Who is funding the study?
The Union for the Promotion of Oil and Protein Plants e.V. (Union zur Foerderung von Oel- und Proteinpflanzen e.V) (Germany)

Who is the main contact?
Prof Andreas F. H. Pfeiffer
afhp@dife.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andreas F. H. Pfeiffer

ORCID ID

Contact details

Arthurt-Scheunert-Allee 114-116
Nuthetal
14558
Germany
+49 (0) 33200 88 2771
afhp@dife.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Single centre, randomized study to investigate the effect of dietary rapeseed (canola) versus olive oil supplementation on serum lipids, liver enzymes and postprandial inflammatory responses in adipose tissue in obese, but otherwise healthy men.

Acronym

Rapeseed and olive oil study

Study hypothesis

Rapeseed and olive oil are both known as favourable nutritional components. Both oils contain a high and almost equal amount of MUFA, whereas rapeseed oil contains more PUFA, especially ALA and n-6 linoleic acid. This study aimed to investigate whether a daily supplementation with 50 g of rapeseed oil has benefical effects on serum lipids, liver enzymes and inflammation compared to a daily supplementation with 50 g of olive oil.

Ethics approval

The ethical committee of the University of Potsdam, Germany, 03/11/2010, ref: 1/2010, 5/29

Study design

Single-centre randomized 4-week dietary intervention study of two arms (rapeseed vs olive oil)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format. Please use the contact information below to request Information material.

Condition

Obesity

Intervention

Eligible individuals were randomized into two treatments to receive a four week daily supplementation with either 50 g of rapeseed oil or 50 g of olive oil. At the end of the supplementation individuals underwent a biopsy of subcutaneous adipose tissue at fasted conditions at 08:30 am, followed by a test meal of 835 kcal and an additional biopsy of subcutaneous adipose tissue four hours after the test meal.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To assess the influence of a daily nutritional supplementation with either 50 g of rapeseed oil or 50 g of olive oil to an isocaloric diet on body composition, serum lipids, serum liver enzymes and inflammatory gene expression in sub cutaneous adipose tissue. Body composition will be determined using an air-displacement plethysmography system and serum lipids and liver enzymes will be measured using standard techniques in a certified laboratory at the German Institute of Human Nutrition before and four weeks after dietary intervention. Inflammatory gene expression in sub cutaneous adipose tissue will be measured four weeks after dietary intervention using quantitative real time-PCR.

Secondary outcome measures

To assess the influence of a daily nutritional supplementation with either 50 g of rapeseed oil or 50 g of olive oil to an isocaloric diet on plasma n-6 and n-3 PUFA content and plasma n-6/n-3 ratio before and four weeks after dietary intervention. n-6 and n-3 PUFA content will be determined after lipid extraction from plasma using thin layer chromatography and gas chromatography. The plasma n-6/n-3 ratio will be calculated.

Overall trial start date

01/09/2010

Overall trial end date

31/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males, age between 18 and 65 years
2. Obesity, BMI between 27-35 kg/m²

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

20 randomised individuals

Participant exclusion criteria

1. Diabetes mellituis
2. Alcohol or drug abuse
3. Any medical treatment that affects glucose metabolism, treatment with corticosteroids, treatment with monoaminooxidase inhibitors
4. Any treatment with anticoagulants or any known diseases that affect blood clotting

Recruitment start date

01/09/2010

Recruitment end date

31/10/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Arthurt-Scheunert-Allee 114-116
Nuthetal
14558
Germany

Sponsor information

Organisation

The Union for the Promotion of Oil and Protein Plants e.V. (Union zur Foerderung von Oel- und Proteinpflanzen e.V) (Germany)

Sponsor details

Claire-Waldoff-Str. 7
Berlin
10117
Germany
+49 (0) 30 31 90 42 02
info@ufop.de

Sponsor type

Research organisation

Website

http://www.ufop.de/

Funders

Funder type

Research organisation

Funder name

The Union for the Promotion of Oil and Protein Plants e.V. (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes