N-3 polyunsaturated fatty acids and obesity
| ISRCTN | ISRCTN11445521 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11445521 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/01/2015
- Registration date
- 20/02/2015
- Last edited
- 08/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Kopernika 15a
Krakow
31501
Poland
| Phone | +48 12 4214006 |
|---|---|
| mbkiec@cyf-kr.edu.pl |
Scientific
Kopernika 15a
Krakow
31-501
Poland
 ORCID ID |
0000-0002-3522-0711 |
|---|---|
| Phone | +48 12 4214006 |
| mbmalec@cyf-kr.edu.pl |
Study information
| Study design | Randomised placebo-controlled double-blind single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| 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 |
| Study objectives | 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(s) | Jagiellonian University Bioethical Committee, 25/06/2009, KBET/82/B/2009 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2009 |
| Completion date | 28/02/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 subjects |
| Total final enrolment | 48 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 31/07/2013 |
Locations
Countries of recruitment
- Poland
Study participating centre
Krakow
31-501
Poland
Sponsor information
University/education
Sw Anny 12
Krakow
30-006
Poland
"ROR" |
https://ror.org/03bqmcz70 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 05/03/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planning to submit manuscripts within 1 month and 6 months |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/05/2015 | 15/02/2022 | Yes | No | |
| Results article | 02/09/2021 | 08/03/2023 | Yes | No | |
| Results article | 16/08/2022 | 08/03/2023 | Yes | No |
Editorial Notes
08/03/2023: Publication references added.
15/02/2022: Publication reference and total final enrolment added.
