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

NCT00540111 | Completed DMC

• 1 other identifier: upeclin/HC/FMB-Unesp-01
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertriglyceridemia; HIV Infections

Keywords

Soluble fiber; HIV/aids; Hypertriglyceridemia; Cytokines; Alternative Medicine; Complementary Medicine

Outcome Measures

Primary Outcomes (1)

• 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.

  four months

Study Arms (1)

1

OTHER

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)

Interventions

soluble fiber® (partially hydrolyzed guar gum) DIETARY_SUPPLEMENT

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.

Also known as: Benefiber® (Novartis)

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of HIV
• Hypertriglyceridemia
• Use of highly active antiretroviral therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Hypertriglyceridemia; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

lactitol

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Juliana Geraix, Nutricionist

  Botucatu Medical School - UNESP

  PRINCIPAL INVESTIGATOR

• Paulo CM Pereira, PhD

  Botucatu Medical School - UNESP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 5, 2007
• Study Start: March 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 10, 2010

Record last verified: 2010-02