Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS (PRECOR-NUT)

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Status: Completed

Conditions: Signs and Symptoms, Digestive; HIV; Dietary Modification; Dyslipidemia

Treatments: Dietary Supplement: Maltodextrin (placebo for symbiotic); Dietary Supplement: Symbiotic; Behavioral: Nutritional intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02180035

CNPq- 478741/2008-1

Details and patient eligibility

About

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).

Enrollment: 290 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnancy
• Breastfeeding
• Opportunistic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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290 participants in 2 patient groups, including a placebo group

Symbiotic & Nutritional intervention

Experimental group

Description:

Symbiotic (dietary fibers + probiotic bacteria) 6g sachet twice daily for 6 months, dietary prescription and nutritional counseling

Treatment:

Behavioral: Nutritional intervention

Dietary Supplement: Symbiotic

Maltodextrin & Nutritional intervention

Placebo Comparator group

Description:

Maltodextrin (placebo for symbiotic) 6g sachet twice daily for 6 months, dietary intervention and nutritional counseling.

Treatment:

Behavioral: Nutritional intervention

Dietary Supplement: Maltodextrin (placebo for symbiotic)