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

Primary Purpose

Hypertriglyceridemia, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
soluble fiber® (partially hydrolyzed guar gum)
Sponsored by
UPECLIN HC FM Botucatu Unesp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring Soluble fiber, HIV/aids, Hypertriglyceridemia, Cytokines, Alternative Medicine, Complementary Medicine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    1

    Arm Description

    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.

    Outcomes

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 4, 2007
    Last Updated
    February 9, 2010
    Sponsor
    UPECLIN HC FM Botucatu Unesp
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00540111
    Brief Title
    Effect of Soluble Fiber on Hypertriglyceridemia and Immune Profile in HIV-positive Individuals.
    Official Title
    Effect of Soluble Fiber on Hypertriglyceridemia and Immune Profile in HIV-positive Individuals on Highly Active Antiretroviral Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    October 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    UPECLIN HC FM Botucatu Unesp
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertriglyceridemia, HIV Infections
    Keywords
    Soluble fiber, HIV/aids, Hypertriglyceridemia, Cytokines, Alternative Medicine, Complementary Medicine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Other
    Arm Description
    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 Type
    Dietary Supplement
    Intervention Name(s)
    soluble fiber® (partially hydrolyzed guar gum)
    Other Intervention Name(s)
    Benefiber® (Novartis)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juliana Geraix, Nutricionist
    Organizational Affiliation
    Botucatu Medical School - UNESP
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Paulo CM Pereira, PhD
    Organizational Affiliation
    Botucatu Medical School - UNESP
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

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