Effect of Soluble Fiber on Hypertriglyceridemia and Immune Profile in HIV-positive Individuals.
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|ClinicalTrials.gov Identifier: NCT00540111|
Recruitment Status : Completed
First Posted : October 5, 2007
Last Update Posted : February 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hypertriglyceridemia HIV Infections||Dietary Supplement: soluble fiber® (partially hydrolyzed guar gum)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Soluble Fiber on Hypertriglyceridemia and Immune Profile in HIV-positive Individuals on Highly Active Antiretroviral Therapy|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||October 2007|
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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540111
|Principal Investigator:||Juliana Geraix, Nutricionist||Botucatu Medical School - UNESP|
|Study Chair:||Paulo CM Pereira, PhD||Botucatu Medical School - UNESP|