Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/01/2015
Date assigned
20/02/2015
Last edited
20/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
The mechanisms involved in maintaining homoeostasis in the body decrease in obesity. Biomarkers might indicate the early metabolic and proinflammatory consequences of obesity. Bioactive compounds like n-3 PUFAs might prevent the decline in organ function in people who are obese. The aim in this study is to find out whether a combined intervention (diet and n-3 PUFA) alters the metabolic, inflammatory and genetic biomarkers in obese subjects.

Who can participate?
Adults who are and are not obese

What does the study involve?
After a detailed medical examination, all individuals will receive 2 weeks of an adaptation diet. Biochemical estimations (at fasting, postprandial tests, oral glucose and oral lipids tolerance tests and genetic tests) will be performed and then all subjects will be assigned to different diet groups (low calorie or isocaloric diet). Additionally, subjects will be randomly allocated to receive n-3 PUFA or placebo for 3 months. Every 2 weeks all subjects will receive intensive group and individual education about dietary habits. Medical examination and laboratory tests will be done.

What are the possible benefits and risks of participating?
The direct benefit for participants is detailed assessment of their health status—medical examination, laboratory tests and ultrasonography (if necessary). There is a very small chance of infection at the site of the insertion of the needle.

Where is the study run from?
Jagiellonian University Medical College (Poland)

When is the study starting and how long is it expected to run for?
From September 2009 to February 2015

Who is funding the study?
European Commission (Belgium)

Who is the main contact?
Professor Aldona Dembinska-Kiec
mbkiec@cyf-kr.edu.pl

Trial website

Contact information

Type

Scientific

Primary contact

Professor Aldona Dembinska-Kiec

ORCID ID

Contact details

Kopernika 15a
Krakow
31501
Poland
+48 12 4214006
mbkiec@cyf-kr.edu.pl

Type

Scientific

Additional contact

Dr Malgorzata Malczewska-Malec

ORCID ID

http://orcid.org/0000-0002-3522-0711

Contact details

Kopernika 15a
Krakow
31-501
Poland
+48 12 4214006
mbmalec@cyf-kr.edu.pl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Caloric restriction and postprandial stress markers in healthy and obese people taking n-3 polyunsaturated fatty acids: BIOmarkers of Robustness of Metabolic Homeostasis for Nutrigenomics-derived Health CLAIMS Made on Food

Acronym

Study hypothesis

1. The post-prandial metabolic and inflammatory biomarkers will be changed in obese compared with healthy, non-obese subjects.
2. Caloric restriction combined with n-3 polyunsaturated fatty acids (n-3 PUFA) supplementation will diminish the post-prandial metabolic and inflammatory responses.
3. The long-term supplementation with marine n-3 PUFA and low calorie diet will protect people from obesity-related complications.

Ethics approval

Jagiellonian University Bioethical Committee, 25/06/2009, KBET/82/B/2009

Study design

Randomised placebo-controlled double-blind single-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Healthy and obese subjects

Intervention

1. Low calorie diet (1200–1500 kcal/day) or isocaloric diet combined marine n-3 PUFA (1.8 g/day) as oral supplements for 3 months
2. Low calorie diet (1200–1500 kcal/day) or isocaloric diet combined with oral placebo for 3 months

Blood samples will be taken at fasting and during postprandial lipids and glucose tolerance tests before and after the intervention.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Changes in metabolic and inflammatory biochemical markers after 3 moths of diet and n-3 PUFA supplementation
2. Changes in lipids and glucose metabolism markers during postprandial state in obese patients before and after intervention
3. Changes in expression of genes in peripheral blood mononuclear cells before and after intervention

Secondary outcome measures

1. Changes in serum glucose-dependent insulinotropic peptide during postprandial period and after diet and n-3 PUFA supplementation
2. Changes in osteocalcin serum concentrations after diet and n-3 PUFA supplementation
3. Lipidomic analysis in serum before and after intervention
4. Changes in serum adipokines and cytokines after diet and n-3 PUFA supplementation
5. Association of gene polymorphisms with response to diet and n-3 PUFA supplementation

Overall trial start date

01/09/2009

Overall trial end date

28/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 25–65 years old
2. Body-mass index (BMI) 25–40 kg/m2
3. Not consuming fish oil or antioxidants
4. Willing to adhere to the study protocol
5. Able to provide written infomed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150 subjects

Participant exclusion criteria

1. Age < 25 years old or > 65 years old
2. BMI < 25 kg/m2 or > 40 kg/m2
3. Diabetes or other endocrine disorders
4. Chronic diseases (e.g., gastrointestinal problems, kidney diseases, liver diseases or cardiovascular problems)
5. Pregnant or planning to become pregnant during the study
6. Use of prescribed medications to control inflammation, blood lipids and glucose
7. Use of fish oil or other diet supplements

Recruitment start date

01/09/2009

Recruitment end date

31/07/2013

Locations

Countries of recruitment

Poland

Trial participating centre

Jagiellonian University Medical College
Kopernika 15a
Krakow
31-501
Poland

Sponsor information

Organisation

Jagiellonian University Medical College

Sponsor details

Sw Anny 12
Krakow
30-006
Poland

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

European Commission (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planning to submit manuscripts within 1 month and 6 months

Intention to publish date

05/03/2015

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes