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

Not Applicable

Completed

• Conditions: Signs and Symptoms, Digestive; HIV; Dietary Modification; Dyslipidemia
• Interventions: Dietary Supplement: Maltodextrin (placebo for symbiotic); Dietary Supplement: Symbiotic; Behavioral: Nutritional intervention

• Registration Number: NCT02180035
• Lead Sponsor: Conselho Nacional de Desenvolvimento Científico e Tecnológico

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2014-07
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-02
• Last Update Submitted: 2014-07-16
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy
• Breastfeeding
• Opportunistic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maltodextrin & Nutritional intervention	Nutritional intervention	Maltodextrin (placebo for symbiotic) 6g sachet twice daily for 6 months, dietary intervention and nutritional counseling.
Symbiotic & Nutritional intervention	Nutritional intervention	Symbiotic (dietary fibers + probiotic bacteria) 6g sachet twice daily for 6 months, dietary prescription and nutritional counseling
Maltodextrin & Nutritional intervention	Maltodextrin (placebo for symbiotic)	Maltodextrin (placebo for symbiotic) 6g sachet twice daily for 6 months, dietary intervention and nutritional counseling.
Symbiotic & Nutritional intervention	Symbiotic	Symbiotic (dietary fibers + probiotic bacteria) 6g sachet twice daily for 6 months, dietary prescription and nutritional counseling

Primary Outcome Measures

Name	Time	Method
Seric lipid levels	Baseline, Week 24	Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C.

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms	Baseline, Week 24	Assessment of the presence of gastrointestinal symptoms (nausea and/or vomiting, dyspepsia, heartburn, diarrhea, flatulence and constipation), associated or not with antiretrorival therapy, before and after intervention to verify their effectiveness in reducing these symptoms.
Body composition	Baseline, Week 24	Changes from baseline in total body fat percentage, percentage of fat in the trunk, percentage of fat in the arms, percentage of fat in the legs and lean body mass percentage.
Anthropometric measures	Baseline, Week 24	Changes from baseline in weight, waist circumference, abdominal circumference, waist-to-hip ratio and Body Mass Index (BMI).
Fasting blood glucose	Baseline, Week 24	Changes from baseline in fasting blood glucose.
Adherence to the nutritional intervention and nutritional appointments	Baseline, Week 24	Assessment of dietary intake modification after intervention and patient's return to nutritional appointments.

Trial Locations

Locations (1)

Outpatient Infectoparasitary Diseases, Hospital das Clinicas, Federal University of Goiás; 🇧🇷 Goiânia, Goiás, Brazil