Transcriptomics of Mononuclear Cells and Inflammatory Status of Obese Patients Treated With Omega-3 Fatty Acids

NCT05219890 | Withdrawn DMC

• 1 other identifier: 1832
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective is to determine the effect that supplementation with 4.8 g/day of w-3 FA \[3.2g eicosapentaenoic acid (EPA) and 1.6 g docosahexaenoic acid (DHA)\] have on the inflammatory state of obese patients (BMI ≥ 35.0 kg/m2), at the metabolic, cellular and molecular levels.

Conditions

Obesity; Inflammation; Immune System Disorder

Keywords

omega-3 fatty acids; DHA; EPA

Outcome Measures

Primary Outcomes (1)

• Changes in serum triglycerides levels

  A reduction in serum triglycerides of at least 5% of initial concentration

  Within the time of intervention, i. e., 3 months

Secondary Outcomes (1)

• Changes in serum levels of inflammatory proteins, including cytokines

  Within the time of intervention, i.e., 3 months

Other Outcomes (1)

• Changes in the Bioenergetic index of PBMNC (monocytes and lymphocytes)

  Within the time of intervention, i.e., 3 months

Study Arms (2)

OBESE PATIENTS

EXPERIMENTAL

Obese patients will be recruited from the outpatient Clinic of Obesity at the INCMNSZ. They will consume the fish oil equivalent to 4.8 g/day of EPA and DHA for 3 months, followed by a one-month period without treatment.

Dietary Supplement: Fish oil

CONTROL GROUP

ACTIVE COMPARATOR

Healthy normal volunteers will be recruited from friends and family of the investigators, and staff at the INCMNSZ. They will consume the fish oil equivalent to 4.8 g/day of EPA and DHA for 3 months, followed by a one-month period without treatment.

Dietary Supplement: Fish oil

Interventions

Fish oil DIETARY_SUPPLEMENT

They will consume the fish oil equivalent to 4.8 g/day of EPA and DHA for 3 months, followed by a one-month period without treatment.

CONTROL GROUP; OBESE PATIENTS

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Control group:
• healthy adult non-obese volunteers (BMI 18.5 to 23.0 kg/m2)
• Obese group:
• metabolically healthy adult obese (BMI ≥ 35.0 kg/m2) patients,

You may not qualify if:

• type 2 diabetes
• hypertension
• liver or kidney failure
• metabolic syndrome
• taking antinflammatory drugs or dietary supplements
• in the case of women, pregnant or lactating

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

MeSH Terms

Conditions

Obesity; Inflammation; Immune System Diseases

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Healthy volunteers and obese patients will consume the same amount of omega-3 fatty acids for the same time.

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: January 16, 2017
• Primary Completion: June 1, 2020
• Study Completion: January 1, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After completion of the study
• Access Criteria: None assigned