NCT01865448

Brief Summary

Comparative, randomized, placebo-controlled, single-centre, single-blind clinical trial to assess the effectiveness of providing additional DHA omega-3 fatty acids supplements to increase the levels of pro-resolving and anti-inflammatory lipid mediators and decrease the biological markers of chronic inflammation in obese patients following a weight-loss programme.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

June 20, 2019

Completed
Last Updated

June 20, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

May 27, 2013

Results QC Date

June 8, 2016

Last Update Submit

March 20, 2019

Conditions

ObesityInflammation

Keywords

Docosahexaenoic AcidsFatty Acids, Omega-3ObesityInflammation

Outcome Measures

Primary Outcomes (3)

  • Proresolution Index

    Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators

    6 months

  • Sum of Proresolving Mediators at 6 Months

    Sum of proresolving mediators at 6 months

    6 months

  • Sum of Proinflammatory Mediators at 6 Months

    Sum of proinflammatory mediators at 6 months

    6 months

Secondary Outcomes (49)

  • Weight at 6 Months

    6 months

  • Body Mass Index at 6 Months

    6 months

  • Waist Circumference at 6 Months

    6 months

  • C-reactive Protein (CRP) at 2 Months

    2 months

  • C-reactive Protein (CRP) at 6 Months

    6 months

  • +44 more secondary outcomes

Study Arms (2)

omega-3 DHA

ACTIVE COMPARATOR

Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.

Dietary Supplement: Omega-3 DHA

Control

PLACEBO COMPARATOR

Patients in control group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme

Other: Placebo

Interventions

Omega-3 DHADIETARY_SUPPLEMENT

Patients take daily 2 tablets of Docosahexaenoic Acid

Also known as: Docosahexaenoic Acid, omega-3 fatty acid, PUFA
omega-3 DHA
PlaceboOTHER

Patients in control group take daily 2 placebo capsule

Also known as: placebo capsule
Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 years
  • Obese patients with Body Mass Index between 30 and 35
  • Patients who agree to participate and sign the Informed Consent form

You may not qualify if:

  • Treatment with acetylsalicylic acid (ASA), non-steroidal anti-inflammatory drugs (NSAIDS), corticoids or thiazolidinedione antidiabetic drugs (glitazones)
  • Pregnant or nursing patients
  • Haemopathy, including clotting disorders
  • Treatment with dicoumarin anticoagulants (Sintrom®)
  • Cancer or a history of cancer who have not received the oncologist's release
  • Type 1 or type 2 diabetes mellitus
  • Immune disorders (rheumatoid arthritis, lupus, etc.) and/or inflammatory disease (ulcerative colitis, Crohn's disease, etc.) that may alter the biological markers of inflammation
  • Patients not expected to attend monitoring visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Support Unit. Río Hortega University Hospital

Valladolid, Spain

Location

MeSH Terms

Conditions

ObesityInflammation

Interventions

Docosahexaenoic AcidsFatty Acids, Omega-3

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Results Point of Contact

Title
Dr. Daniel de Luis
Organization
Unidad de Apoyo a la Investigacion. Hospital Rio Hortega
dadluis@yahoo.es
983420400

Study Officials

  • Daniel De Luis, PhD

    Unidad de Apoyo a la Investigacion. Hospital Rio Hortega

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2013

First Posted

May 30, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

June 20, 2019

Results First Posted

June 20, 2019

Record last verified: 2019-03

Locations

ES(1)