Effect of Treatment Nutritional With Supplementation About Biochemical Profile and Anthropometry in Adult Patients With HIV/AIDS

Conselho Nacional de Desenvolvimento Científico e Tecnológico1 site in 1 country290 target enrollmentOctober 2009

ConditionsDietary Modification Dyslipidemia Signs and Symptoms, Digestive HIV

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dietary Modification
Sponsor: Conselho Nacional de Desenvolvimento Científico e Tecnológico
Enrollment: 290
Locations: 1
Primary Endpoint: Seric lipid levels
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate if nutritional treatment with nutritional supplementation of dietary fiber reduces cholesterol levels and triglycerides (dyslipidemia) in patients with HIV/AIDS receiving antiretroviral therapy (HAART).

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

July 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Responsible Party

Principal Investigator

Marianne de Oliveira Falco

Effect of Treatment With Nutritional Eating Plan and Supplementation With Dietary Fibers in Adult Patients With HIV / AIDS

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Eligibility Criteria

Inclusion Criteria

•HIV-infected patients
•Adults (≥ 19 years old)
•On highly active antiretroviral therapy (HAART)

Exclusion Criteria

•Pregnancy
•Breastfeeding
•Opportunistic disease

Outcomes

Primary Outcomes

Seric lipid levels

Time Frame: Baseline, Week 24

Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C.

Secondary Outcomes

Gastrointestinal symptoms(Baseline, Week 24)
Body composition(Baseline, Week 24)
Anthropometric measures(Baseline, Week 24)
Fasting blood glucose(Baseline, Week 24)
Adherence to the nutritional intervention and nutritional appointments(Baseline, Week 24)