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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list