N-3 polyunsaturated fatty acids and obesity

• Register: ISRCTN
• Last refreshed on: 20 March 2023
• Main ID: ISRCTN11445521
• Date of registration: 20/02/2015
• Prospective Registration: No
• Primary sponsor: Jagiellonian University Medical College
• Public title: N-3 polyunsaturated fatty acids and obesity
• 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
• Date of first enrolment: 01/09/2009
• Target sample size: 150
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN11445521
• Study type: Interventional
• Study design: Randomised placebo-controlled double-blind single-centre study (Prevention)
• Phase: Not Applicable

Countries of recruitment

Poland

Contacts

• Name: Aldona Dembinska-Kiec

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy and obese subjects
Nutritional, Metabolic, Endocrine
Obesity

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

European Commission (Belgium)

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 28/02/2015