Effect of Soluble Fiber on Hypertriglyceridemia and Immune Profile in HIV-positive Individuals.

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00540111
First received: October 4, 2007
Last updated: February 9, 2010
Last verified: February 2010
  Purpose

The purpose of this study was to assess the effect of soluble fiber® (partially hydrolyzed guar gum) supplementation on hypertriglyceridemia and immune profile in HIV-positive individuals on HAART.


Condition Intervention
Hypertriglyceridemia
HIV Infections
Dietary Supplement: soluble fiber® (partially hydrolyzed guar gum)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Soluble Fiber on Hypertriglyceridemia and Immune Profile in HIV-positive Individuals on Highly Active Antiretroviral Therapy

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • Serum TG and TG/HDL-c ratio reduction was observed at all time points, but statistical significance was found just at M0 and M2. Regarding serum cytokines, TNFα- and IL-6 significantly decreased between M0 and M2, and only IL-6 reduced between M1 and M2. [ Time Frame: four months ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: March 2005
Study Completion Date: October 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1

Study of intervention, prospective,uncontrolled Group Number: 1

Group Type:Other - the subjects of group were compared the initial moment (M0 - moment without soluble fiber supplementation)with the others two moments: M1 (one month after soluble fiber supplementation) and M2 (four months after soluble fiber supplementation).

Group Description - HIV-positive individuals with hypertriglyceridemia (serum levels ≥ 200 to ≤ 500 mg/dL),who had been on the same HAART regimen for at least 6 months, had no change in therapy during the study.

Intervention:Received 20g/day of soluble fiber® (partially hydrolyzed guar gum) for 4 months at pre-established times.

Dietary Supplement: soluble fiber® (partially hydrolyzed guar gum)
HIV-positive individuals with hypertriglyceridemia and who had been on the same HAART regimen for at least 6 months, had no change in therapy during the study,received 20g/day of soluble fiber for 4 months at pre-established times.
Other Name: Benefiber® (Novartis)

Detailed Description:

Since 1996, the advent of highly active antiretroviral therapy (HAART) has caused a profound impact on the natural history of HIV-infection by promoting important and sustainable viral replication suppression and increasing survival and quality of life among seropositive patients. Nonetheless, antiretroviral therapy has been observed to be accompanied by metabolic alterations such as dyslipidemia, especially hypertriglyceridemia, insulin resistance, hyperglycemia and lipodystrophy (body fat redistribution). Epidemiological studies have demonstrated a correlation between high triglyceride (TG) levels and higher incidence of coronary artery disease (CAD). Some investigators suggest dietary intervention as part of hyperlipidemia treatment, including an increase in soluble fiber intake (10-25g/day). Whereas some studies have demonstrated that both cholesterol and serum triglyceride levels decrease with the use of food fiber, others have shown just a serum triglyceride increase, and others failed to observe any alteration in lipid metabolism. The purpose of this study was to assess the effect of soluble fiber® (partially hydrolyzed guar gum) supplementation on hypertriglyceridemia and immune profile in HIV-positive individuals on HAART. Nineteen HIV-positive individuals with hypertriglyceridemia (serum levels ≥ 200 to ≤ 500 mg/dL) were studied. Of these individuals, 63.16% were males (mean age of 38.52±9.29 years) who had been on the same HAART regimen for at least 6 months, had no change in therapy during the study and received 20g/day of soluble fiber for 4 months at pre-established times. Clinical-nutritional, biochemical (total proteins, albumin, globulin, total cholesterol, LDL-c, HDL-c, TG, TG/HDL-c and LDL-c/HDL-c), hemoximetric (hemoglobin, hematocrit and total lymphocytes), and immunologic (lymphocytes T CD4+, T CD8+; T CD4+/CD8+ ratio, viral load, TNFα- and IL-6) parameters were assessed in all patients at three time points (M0-pretreatment, M1-30 days and M2-4 months after intervention). Significance level was set 5% for all data statistically analyzed. Serum TG and TG/HDL-c ratio reduction was observed at all time points, but statistical significance was found just at M0 and M2. The remaining biochemical, hemoximetric and immunologic parameters (lymphocytes T CD4+, T CD8+; T CD4+/CD8+ ratio, and viral load) showed no significant difference at all times. Regarding serum cytokines, TNFα- and IL-6 significantly decreased between M0 and M2, and only IL-6 reduced between M1 and M2. The data collected show that dietary and anthropometric parameters remained unchanged excluding potential confounding factors related with the effect of fiber supplementation on serum TG, TNFα- and IL-6. Thus, soluble fiber® (partially hydrolyzed guar gum) contributed to an important reduction in hypertriglyceridemia and in the serum levels of the proinflammatory cytokines TNFα- and IL-6 in HIV-seropositive individuals on HAART. In addition, soluble fiber® (partially hydrolyzed guar gum) might have minimized the process of atherosclerosis in these individuals, given that elevated serum levels of TG, TNFα- and IL-6 have been associated with the development of these lesions.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of HIV
  • Hypertriglyceridemia
  • Use of highly active antiretroviral therapy

Exclusion Criteria:

  • Use of hypolipemic drugs
  • Use of highly active antiretroviral therapy under six months
  • Pregnant
  • Insulin independent diabetes
  • Thyroid disease
  • Others infectious
  • Alcoholic
  • Under 18 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540111

Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Juliana Geraix, Nutricionist Botucatu Medical School - UNESP
Study Chair: Paulo CM Pereira, PhD Botucatu Medical School - UNESP
  More Information

No publications provided

Responsible Party: Botucatu Medical School - UNESP, Juliana Geraix
ClinicalTrials.gov Identifier: NCT00540111     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-01
Study First Received: October 4, 2007
Last Updated: February 9, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:
Soluble fiber
HIV/aids
Hypertriglyceridemia
Cytokines
Alternative Medicine
Complementary Medicine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Hypertriglyceridemia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 28, 2014