Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/09/2012
Date assigned
03/10/2012
Last edited
27/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The most common form of diabetes, type 2 diabetes mellitus (T2DM), is a growing health problem worldwide. T2DM is linked to a number of severe complications, as well as increasing the risk of heart disease (cardiovascular disease) and cancer. There is a great deal of evidence to suggest that these diseases are caused by too much sugar in the blood (hyperglycaemia), which leads to an increase of free radicals causing irreversible damage cells (oxidative stress). Studies have shown that a healthy diet can help to prevent oxidative stress as it is rich in vitamins and minerals that are important for repairing and protecting the cells in the body. Additionally, there is evidence that replacing saturated fatty acids (SFA) in the diet with polyunsaturated fatty acids (PUFA) such as omera-3 can also help to protect the body and prevent diseases. This study aims to investigate the potential of a vegetable and PUFA rich diet to reduce levels of oxidative stress, and to see whether the results of this will be the same in diabetic and non-diabetic people.

Who can participate?
Adults with insulin treated (ITDM2) or non-insulin dependent (NIDDM) type 2 diabetes, and healthy age-matched controls.

What does the study involve?
All participants (both diabetics and non-diabetics) are randomly assigned into one of two groups. The first group (control group) are provided with information about the benefits of a healthy diet, specifically about the importance of fat quality and the role of vegetables in a balanced diet. The second group (intervention group) are provided with the same information, but are also given 300g vegetables and 25ml of plant oil, as a replacement for saturated fats, to eat every day for 8 weeks. Blood samples are taken before the intervention starts, after 4 weeks (half way through the intervention), after 8 days (the end of the intervention period), and after 16 weeks (8 weeks after the end of the intervention period).

What are the possible benefits and risks of participating?
There are no specific benefits of participating aside from the potential health benefits of eating more vegetables and reducing saturated fat in the diet. There are no risks, except for the possibility of digestive discomfort because of the change to the diet.

Where is the study run from?
University of Vienna (Austria)

When is the study starting and how long is it expected to run for?
January 2009 to December 2012

Who is funding the study?
1. European Union through the cross-border cooperation programme (Slovakia - Austria)
2. Austrian Ministry of Health (Austria)

Who is the main contact?
Professor Karl-Heinz Wagner

Trial website

Contact information

Type

Scientific

Primary contact

Prof Karl-Heinz Wagner

ORCID ID

Contact details

University of Vienna
Althanstrasse 14
Vienna
1090
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of natural food products on complications in diabetes mellitus type 2

Acronym

DIAPLANT

Study hypothesis

A diet rich in vegetables and a polyunsaturated fatty acids (PUFA) rich plant oil improves DNA stability in type 2 diabetic subjects.

Ethics approval

Ethical Committee of the City of Vienna, 16/11/2009, ref: EK09-218-VK_NZ

Study design

Randomized prospective randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 2 diabetes and complications of Type 2 Diabetes mainly cardiovascular disease

Intervention

All participants (diabetics and non-diabetics) receive information about the beneficial effects of a healthy diet with special focus on the importance of fat quality and the role of vegetables in a balanced diet. Participants are randomly assigned to the “intervention” or “information only” group.

Subjects of the “information only” group received only the above mentioned information, while subjects of the “intervention” group received additionally 300 g of vegetables and 25 ml of plant oil per day. The participants are instructed to use the plant oil as replacement for saturated fatty acids (SFA). A reference “cup” and a booklet with recipes, instructions for replacement of SFA and usage of the plant oil (oil is not allowed to be heated up, but added to warm foods) is provided to the participants. A variety of frozen vegetables is given to subjects every 2 weeks. Participants can choose the order of consumption of the provided vegetables. A dietary diary has to be completed, and fatty acid profile, γ-tocopherol and carotenoid concentrations in plasma are measured to monitor compliance.

The intervention period lasts 8 weeks, followed by a period of 8 weeks in which no intervention food is provided. Blood samples are taken before the intervention, after 4, 8 (end of intervention period) and 16 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. DNA damage (single and double strand breaks): Comet assay in peripheral blood mononucleated cells (PBMCs), performed at baseline, after 4, 8 (end of intervention) and 16 weeks
2. Chromosomal damage: Cytokinesis-block micronucleus assay in PBMCs and buccal cells, performed at baseline and after 8 weeks

Secondary outcome measures

1. Lipid metabolism: total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides (enzymatically, Aeroset, Abbott Diagnostics), LDL-subfractions (Lipoprint LDL system) performed at baseline, after 4, 8 (end of intervention) and 16 weeks, except for LDL subfractions, which were measured at baseline and after 4 and 8 weeks
2. Glucose metabolism: fasting plasma glucose (enzymatically by the hexokinase method; Aeroset, Abbott Diagnostics), glycosylated haemoglobin (automated Glycohemoglobin Analyzer), performed at baseline, after 4, 8 (end of intervention) and 16 weeks
3. Inflammation: IL-6 (Elisa), C-reactive protein (CRP) (hs-Elisa), performed at baseline, after 4 and 8 weeks
4. Metabolomics: LCMS-based analysis, performed at baseline and after 8 weeks

Overall trial start date

01/01/2009

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Stable metabolic control (constant medication regarding glucose, lipid and uric acid metabolism)
2. Glycated haemoglobin (HbA1c) concentration <9.5%
3. Serum total cholesterol (TC) <300 mg/dl (<7.76 mmol/l)
4. Serum triglycerides (TG) <500 mg/dl (<5.7 mmol/l)
5. Serum creatinine <2.5 mg/dl (<221 µmol/l)
6. Stable body weight, constant dietary habits and physical activity levels for at least four weeks before entry to the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Change of dietary habits
2. Frequency of physical activity or body weight within the study period
3. Smoking
4. Intake of fish oil capsules and other fatty acid supplements
5. Change of medication

Recruitment start date

01/01/2009

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Austria

Trial participating centre

University of Vienna
Vienna
1090
Austria

Sponsor information

Organisation

European Regional Development Fund (EFRE) (Austria)

Sponsor details

Schlesingerplatz 2
Vienna
1080
Austria

Sponsor type

Government

Website

http://www.sk-at.eu

Funders

Funder type

Government

Funder name

European Union (EU), through the cross-border cooperation programme Slovakia – Austria 2007-2013 (http://www.sk-at.eu) ref: N00039

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Austrian Ministry of Health (Austria)

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

2013 Results: http://www.ncbi.nlm.nih.gov/pubmed/23340810
2013 Results: http://www.ncbi.nlm.nih.gov/pubmed/24311117

Publication citations

Additional files

Editorial Notes