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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865448
• Other study ID #: PNK-DHA-2013-01
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2019
• Source: Protein Supplies SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Obesity
• Weight Loss

Intervention

Dietary Supplement:
• Omega-3 DHA
Patients take daily 2 tablets of Docosahexaenoic Acid

Other:
• Placebo
Patients in control group take daily 2 placebo capsule

Locations

Country	Name	City	State
Spain	Research Support Unit. Río Hortega University Hospital	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Protein Supplies SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proresolution Index	Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators	6 months
Primary	Sum of Proresolving Mediators at 6 Months	Sum of proresolving mediators at 6 months	6 months
Primary	Sum of Proinflammatory Mediators at 6 Months	Sum of proinflammatory mediators at 6 months	6 months
Secondary	Weight at 6 Months	Weight at 6 months (end of the monitoring period)	6 months
Secondary	Body Mass Index at 6 Months	Body mass index at 6 months (end of the monitoring period)	6 months
Secondary	Waist Circumference at 6 Months	Waist circumference at 6 Months (end of the monitoring period)	6 months
Secondary	C-reactive Protein (CRP) at 2 Months	Level of c-reactive protein (CRP) at 2 months	2 months
Secondary	C-reactive Protein (CRP) at 6 Months	Level of c.reactive protein (CRP) at 6 months	6 months
Secondary	Adiponectin at 2 Months	Level of Adiponectin at 2 months	2 months
Secondary	Adiponectin at 6 Months	Level of Adiponectin at 6 months	6 months
Secondary	Tnf Alpha at 2 Months	Level of Tnf alpha at 2 months	2 months
Secondary	Tnf Alpha at 6 Months	Level of Tnf alpha at 6 months	6 months
Secondary	Interleukin-6 at 2 Months	Level of Interleukin-6 at 2 months	2 months
Secondary	Interleukin-6 at 6 Months	Level of Interleukin-6 at 6 months	6 months
Secondary	Resistin at 2 Months	Level of Resistin at 2 months	2 months
Secondary	Resistin at 6 Months	Level of Resistin at 6 months	6 months
Secondary	Leptin at 2 Months	Level of Leptin at 2 months	2 months
Secondary	Leptin at 6 Months	Level of Leptin at 6 months	6 months
Secondary	15-HETE at 2 Months	Level of 15-HETE at 2 months	2 months
Secondary	15-HETE at 6 Months	Level of 15-HETE at 6 months	6 months
Secondary	12-HETE at 2 Months	Level 12-HETE at 2 months	2 month
Secondary	12-HETE at 6 Months	Level of 12-HETE at 6 months	6 months
Secondary	8-HETE at 2 Months	Level of 8-HETE at 2 months	2 months
Secondary	8-HETE at 6 Months	Level of 8-HETE at 6 months	6 months
Secondary	5-HETE at 2 Months	Level of 5-HETE at 2 months	2 months
Secondary	5-HETE at 6 Months	Level of 5-HETE at 6 months	6 months
Secondary	TXB2 at 2 Months	Level of TXB2 at 2 months	2 months
Secondary	TXB2 at 6 Months	Level of TXB2 at 6 months	6 months
Secondary	PGE2 at 2 Months	Level of PGE2 at 2 months	2 months
Secondary	PGE2 at 6 Months	Level of PGE2 at 6 months	6 months
Secondary	LTB4 at 2 Months	Level of LTB4 at 2 months	2 months
Secondary	LTB4 at 6 Months	Level of LTB4 at 6 months	6 months
Secondary	17-HDOHE at 2 Months	Level of 17-HDOHE at 2 months	2 months
Secondary	17-HDOHE at 6 Months	Level of 17-HDOHE at 6 months	6 months
Secondary	14-HDOHE at 2 Months	Level of 14-HDOHE at 2 months	2 months
Secondary	14-HDOHE at 6 Months	Level of 14-HDOHE at 6 months	6 months
Secondary	7-HDOHE at 2 Months	Level of 7-HDOHE at 2 months	2 months
Secondary	7-HDOHE at 6 Months	Level of 7-HDOHE at 6 months	6 months
Secondary	4-HDOHE at 2 Months	Level of 4-HDOHE at 2 months	2 months
Secondary	4-HDOHE at 6 Months	Level of 4-HDOHE at 6 months	6 months
Secondary	RVD2 at 2 Months	Level of RVD2 at 2 motnhs	2 months
Secondary	RVD2 at 6 Months	Level of RVD2 at 6 months	6 months
Secondary	PD1 at 2 Months	Level of PD1 at 2 months	2 months
Secondary	PD1 at 6 Months	Level of PD1 at 6 months	6 months
Secondary	7SMAR1 at 2 Months	Level of 7SMAR1 at 2 months	2 months
Secondary	7SMAR1 at 6 Months	Level of 7SMAR1 at 6 months	6 months
Secondary	7RMAR1 at 2 Months	Level of 7RMAR1 at 2 months	2 months
Secondary	7RMAR1 at 6 Months	Level of 7RMAR1 at 6 months	6 months
Secondary	Sum of Proinflammatory Mediators at 2 Months	sum of proinflammatory mediators at 2 months	2 months
Secondary	Sum of Proresolving Mediators at 2 Months	sum of proresolving mediators at 2 months	2 months
Secondary	Proresolution Index	Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators	2 months
Secondary	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