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