Effect of Soluble Fiber on Hypertriglyceridemia and Immune Profile in HIV-positive Individuals.
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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 |
- 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.
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
![](https://webarchive.library.unt.edu/web/20130305102258im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Principal Investigator: | Juliana Geraix, Nutricionist | Botucatu Medical School - UNESP |
Study Chair: | Paulo CM Pereira, PhD | Botucatu Medical School - UNESP |
![](https://webarchive.library.unt.edu/web/20130305102258im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 March 03, 2013