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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

October 4, 2007
February 9, 2010
March 2005
July 2007   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00540111 on ClinicalTrials.gov Archive Site
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Effect of Soluble Fiber on Hypertriglyceridemia and Immune Profile in HIV-positive Individuals.
Effect of Soluble Fiber on Hypertriglyceridemia and Immune Profile in HIV-positive Individuals on Highly Active Antiretroviral Therapy

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertriglyceridemia
  • HIV Infections
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)
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.

Intervention: Dietary Supplement: soluble fiber® (partially hydrolyzed guar gum)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
October 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00540111
upeclin/HC/FMB-Unesp-01
Yes
Botucatu Medical School - UNESP, Juliana Geraix
UPECLIN HC FM Botucatu Unesp
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Juliana Geraix, Nutricionist Botucatu Medical School - UNESP
Study Chair: Paulo CM Pereira, PhD Botucatu Medical School - UNESP
UPECLIN HC FM Botucatu Unesp
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP