Omega-3 Supplementation in HIV Patients With Therapeutic Lifestyle Change Diet.

NCT02537236 | Completed Phase 3 DMC

• 1 other identifier: omega-3-HIV/2009
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The positive patients to the Human Immunodeficiency Virus (HIV) with Highly Active Antiretroviral Therapy (HAART) present multiple alterations in their corporal composition and dyslipidemia, wich increase the cardiovascular risk. The investigators evaluated the efficiency of the combination of fish oil omega 3 fatty acids to different doses with the Therapeutic Lifestyle Changes (TLC) diet of the National Cholesterol Education Program on the profile of lipids and the corporal weight in patients with HIV treated with HAART.

Conditions

Human Immunodeficiency Virus

Keywords

Omega-3 Fatty Acids; Therapeutic Lifestyle Changes; Human Immunodeficiency Virus; Cardiac Risk; Dyslipidemia

Outcome Measures

Primary Outcomes (21)

• Triglycerides (TG)

  Serum TG measured at baseline, before initiating treatment.

  At baseline

• Total cholesterol (TC)

  Serum TC measured at baseline, before initiating treatment.

  At baseline

• High density cholesterol (HD-C)

  Serum HD-C measured at baseline, before initiating treatment

  At baseline

• Low density cholesterol (LD-C)

  Serum LD-C measured at baseline, before initiating treatment

  At baseline

• Very low density cholesterol (VLD-C)

  Serum VLD-C measured at baseline, before initiating treatment

  At baseline

• Body weight

  Total weight before initiating treatment.

  At baseline

• Body mass index (BMI)

  BMI obtained before initiating treatment

  At baseline

• TG 4

  Serum TG measured at week four of treatment.

  At week four of treatment

• TC 4

  Serum TC measured at week four of treatment.

  At week four of treatment

• HD-C 4

  Serum HD-C measured at week four of treatment.

  At week four of treatment

• LD-C 4

  Serum LD-C measured at week four of treatment.

  At week four of treatment

• VLD-C 4

  Serum VLD-C measured at week four of treatment.

  At week four of treatment

• Weight 4

  Total weight before at week four of treatment.

  At week four of treatment

• BMI 4

  BMI obtained at week four of treatment

  At week four of treatment

• TG 12

  Serum TG measured at week four of treatment.

  At week twelve of treatment

• TC 12

  Total serum TG measured at week twelve of treatment

  At week twelve of treatment

• HD-C 12

  Serum HD-C measured at week twelve of treatment

  At week twelve of treatment

• LD-C 12

  Serum LD-C measured at week twelve of treatment

  At week twelve of treatment

• VLD-C 12

  Serum VLD-C measured at week twelve of treatment

  At week twelve of treatment

• Weight 12

  Total weight before at week twelve of treatment.

  At week twelve of treatment

• BMI 12

  BMI obtained at week twelve of treatment

  At week twelve of treatment

Study Arms (5)

Group one

EXPERIMENTAL

20 subjects received Therapeutic Lifestyle Changes diet more 1.05 grams of fish oil omega 3 fatty acids

Dietary Supplement: Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention.

Group two

ACTIVE COMPARATOR

20 subjects received conventional diet more 1.05 grams of fish oil omega 3 fatty acids

Dietary Supplement: Omega-3 fatty acids

Group three

EXPERIMENTAL

20 subjects received Therapeutic Lifestyle Changes diet more 2.10 grams of fish oil omega 3 fatty acids.

Dietary Supplement: Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention.

Group four

ACTIVE COMPARATOR

20 subjects received conventional diet more 2.10 grams of fish oil omega 3 fatty acids

Dietary Supplement: Omega-3 fatty acids

Group five

PLACEBO COMPARATOR

20 subjects, control group received conventional diet.

Behavioral: TLC nutritional intervention

Interventions

Omega-3 fatty acids DIETARY_SUPPLEMENT

Omega-3 fatty acid supplementation with fish oil.

Also known as: eicosapentaenoic acid, docosahexaenoic acid

Group four; Group two

TLC nutritional intervention BEHAVIORAL

nutritional orientation.

Group five

Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention. DIETARY_SUPPLEMENT

Omega 3 fatty acid supplementation with fish oil and nutritional counseling of TLC diet.

Group one; Group three

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients positive to Human Immunodeficiency Virus or Acquired Immunodeficiency Syndrome
• Patients older than 18 years positive to HIV/AIDS with HAART
• Patients who agreed to sign consent under written information
• Patients that had some type of dyslipidemia according the Mexican Norms of 2002.

You may not qualify if:

• Patient with mouth non-permeable
• Patients with intolerance or allergy to fish oil
• Patient record in the database SMART but inactive.
• Patients who use or have used in the last 6 weeks food supplements that modify lipids.
• Patient who have not attended two of the four set appointments for valuation.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead
• Hospital Civil de Guadalajara: collaborator

Related Publications (3)

• Carr A, Samaras K, Burton S, Law M, Freund J, Chisholm DJ, Cooper DA. A syndrome of peripheral lipodystrophy, hyperlipidaemia and insulin resistance in patients receiving HIV protease inhibitors. AIDS. 1998 May 7;12(7):F51-8. doi: 10.1097/00002030-199807000-00003.

  PMID: 9619798 BACKGROUND

• Mulligan K, Grunfeld C, Tai VW, Algren H, Pang M, Chernoff DN, Lo JC, Schambelan M. Hyperlipidemia and insulin resistance are induced by protease inhibitors independent of changes in body composition in patients with HIV infection. J Acquir Immune Defic Syndr. 2000 Jan 1;23(1):35-43. doi: 10.1097/00126334-200001010-00005.

  PMID: 10708054 BACKGROUND

• Wohl DA, Tien HC, Busby M, Cunningham C, Macintosh B, Napravnik S, Danan E, Donovan K, Hossenipour M, Simpson RJ Jr. Randomized study of the safety and efficacy of fish oil (omega-3 fatty acid) supplementation with dietary and exercise counseling for the treatment of antiretroviral therapy-associated hypertriglyceridemia. Clin Infect Dis. 2005 Nov 15;41(10):1498-504. doi: 10.1086/497273. Epub 2005 Oct 11.

  PMID: 16231263 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Dyslipidemias

Interventions

Fatty Acids, Omega-3; Eicosapentaenoic Acid; Docosahexaenoic Acids; Fish Oils

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils; Eicosanoids

Study Officials

• Alejandro González-Ojeda, MD. PhD. F.A.C.S.

  Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., Ph.D., F.A.C.S.

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 1, 2015
• Study Start: January 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 2, 2015

Record last verified: 2015-08