Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment

Study to Assess the Effects of DHA (Docosahexaenoic Acid) on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Obesity
• Intervention / Treatment: Dietary supplement: Omega-3 DHA; Other: Placebo

Detailed Description

Will include obese patients (BMI between 30 and 35) who are following a standardized, multidisciplinary weight-loss programme (PronoKal® Method), which consists of a very-low-calorie diet based on protein packets and vegetables with a low glycemic index, into which natural foods are gradually reintroduced, accompanied by physical exercise and emotional support.

Patients who are being treated with acetylsalicylic acid (ASA), non-steroidal anti-inflammatory drugs (NSAIDS), corticoids or thiazolidinedione antidiabetic drugs (glitazones); and patients with immune disorders (rheumatoid arthritis, Lupus, etc.) and/or inflammatory disease (ulcerative colitis, Crohn's disease, etc.) who may alter the biological markers of inflammation,will be excluded.

Treatment: In addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme, the patients will receive an additional 500 mg/day supplement of DHA omega-3 fatty acids in capsule form (study group) or a placebo capsule (control group).

The follow up will be 6 months and patients will be monitored over the course of 6 control visits: baseline, 7 days, 15 days, 30 days, 60 days and 180 days.

The main objective is to assess the effectiveness of providing additional DHA 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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain
    • Research Support Unit. Río Hortega University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 75 years
• Obese patients with Body Mass Index between 30 and 35
• Patients who, regardless of their inclusion in this study, are going to follow the standardized weight-loss programme (PronoKal® Method)
• Patients who agree to participate and sign the Informed Consent form

Exclusion Criteria:

• Treatment with Omega-3 fatty acid supplements for other reasons during the month prior to inclusion in the trial
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: omega-3 DHA; 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; Patients take daily 2 tablets of Docosahexaenoic Acid; Other Names: Docosahexaenoic Acid; PUFA; omega-3 fatty acid
Placebo Comparator: Control; 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; Patients in control group take daily 2 placebo capsule; Other Names: placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight at 6 Months	Weight at 6 months (end of the monitoring period)	6 months
Body Mass Index at 6 Months	Body mass index at 6 months (end of the monitoring period)	6 months
Waist Circumference at 6 Months	Waist circumference at 6 Months (end of the monitoring period)	6 months
C-reactive Protein (CRP) at 2 Months	Level of c-reactive protein (CRP) at 2 months	2 months
C-reactive Protein (CRP) at 6 Months	Level of c.reactive protein (CRP) at 6 months	6 months
Adiponectin at 2 Months	Level of Adiponectin at 2 months	2 months
Adiponectin at 6 Months	Level of Adiponectin at 6 months	6 months
Tnf Alpha at 2 Months	Level of Tnf alpha at 2 months	2 months
Tnf Alpha at 6 Months	Level of Tnf alpha at 6 months	6 months
Interleukin-6 at 2 Months	Level of Interleukin-6 at 2 months	2 months
Interleukin-6 at 6 Months	Level of Interleukin-6 at 6 months	6 months
Resistin at 2 Months	Level of Resistin at 2 months	2 months
Resistin at 6 Months	Level of Resistin at 6 months	6 months
Leptin at 2 Months	Level of Leptin at 2 months	2 months
Leptin at 6 Months	Level of Leptin at 6 months	6 months
15-HETE at 2 Months	Level of 15-HETE at 2 months	2 months
15-HETE at 6 Months	Level of 15-HETE at 6 months	6 months
12-HETE at 2 Months	Level 12-HETE at 2 months	2 month
12-HETE at 6 Months	Level of 12-HETE at 6 months	6 months
8-HETE at 2 Months	Level of 8-HETE at 2 months	2 months
8-HETE at 6 Months	Level of 8-HETE at 6 months	6 months
5-HETE at 2 Months	Level of 5-HETE at 2 months	2 months
5-HETE at 6 Months	Level of 5-HETE at 6 months	6 months
TXB2 at 2 Months	Level of TXB2 at 2 months	2 months
TXB2 at 6 Months	Level of TXB2 at 6 months	6 months
PGE2 at 2 Months	Level of PGE2 at 2 months	2 months
PGE2 at 6 Months	Level of PGE2 at 6 months	6 months
LTB4 at 2 Months	Level of LTB4 at 2 months	2 months
LTB4 at 6 Months	Level of LTB4 at 6 months	6 months
17-HDOHE at 2 Months	Level of 17-HDOHE at 2 months	2 months
17-HDOHE at 6 Months	Level of 17-HDOHE at 6 months	6 months
14-HDOHE at 2 Months	Level of 14-HDOHE at 2 months	2 months
14-HDOHE at 6 Months	Level of 14-HDOHE at 6 months	6 months
7-HDOHE at 2 Months	Level of 7-HDOHE at 2 months	2 months
7-HDOHE at 6 Months	Level of 7-HDOHE at 6 months	6 months
4-HDOHE at 2 Months	Level of 4-HDOHE at 2 months	2 months
4-HDOHE at 6 Months	Level of 4-HDOHE at 6 months	6 months
RVD2 at 2 Months	Level of RVD2 at 2 motnhs	2 months
RVD2 at 6 Months	Level of RVD2 at 6 months	6 months
PD1 at 2 Months	Level of PD1 at 2 months	2 months
PD1 at 6 Months	Level of PD1 at 6 months	6 months
7SMAR1 at 2 Months	Level of 7SMAR1 at 2 months	2 months
7SMAR1 at 6 Months	Level of 7SMAR1 at 6 months	6 months
7RMAR1 at 2 Months	Level of 7RMAR1 at 2 months	2 months
7RMAR1 at 6 Months	Level of 7RMAR1 at 6 months	6 months
Sum of Proinflammatory Mediators at 2 Months	sum of proinflammatory mediators at 2 months	2 months
Sum of Proresolving Mediators at 2 Months	sum of proresolving mediators at 2 months	2 months
Proresolution Index	Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators	2 months
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Number of Participants with Adverse Events as a Measure of Safety and Tolerability of standardized weight-loss programme (PronoKal® Method)and Safety and Tolerability of DHA Supplements	6 months

Collaborators and Investigators

• Sponsor: Protein Supplies SL
• Investigators: Principal Investigator: Daniel De Luis, PhD, Unidad de Apoyo a la Investigacion. Hospital Rio Hortega

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: May 27, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): May 30, 2013

Study Record Updates

• Last Update Posted (Actual): June 20, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Inflammation; Obesity; Fatty Acids, Omega-3; Docosahexaenoic Acids
• Additional Relevant MeSH Terms: Pathologic Processes; Body Weight; Body Weight Changes; Inflammation; Weight Loss
• Other Study ID Numbers: PNK-DHA-2013-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No