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

Study Overview
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Brief Summary
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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).

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

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

Intervention / Treatment
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* Dietary Supplement: Symbiotic
* Dietary Supplement: Maltodextrin (placebo for symbiotic)
* Behavioral: Nutritional intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected patients Adults (≥ 19 years old) On highly active antiretroviral therapy (HAART) Exclusion Criteria: Pregnancy Breastfeeding Opportunistic disease

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symbiotic & Nutritional intervention<br>Symbiotic (dietary fibers + probiotic bacteria) 6g sachet twice daily for 6 months, dietary prescription and nutritional counseling | Dietary Supplement: Symbiotic<br>* 6g sachet composition: Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus acidophillus, Bifidobacterium lactis and fructooligosaccharides. Each patient was instructed to consume two sachets per day, one in the morning and another before bedtime, diluted in 100 ml of filtered or boiled water at room temperature. The dietary supplement should be taken every day for 6 months.<br>Behavioral: Nutritional intervention<br>* Nutritional intervention consists of dietary prescription (nutritional eating plan) for healthy eating based on the Dietary Guidelines for the Brazilian Population and Clinical Manual on Food and Nutrition in HIV-infected Adults Care, both Brazil Ministry of Health guidelines, in addition to nutritional counseling for preexistent clinical conditions.<br>|
| Placebo Comparator: Maltodextrin & Nutritional intervention<br>Maltodextrin (placebo for symbiotic) 6g sachet twice daily for 6 months, dietary intervention and nutritional counseling. | Dietary Supplement: Maltodextrin (placebo for symbiotic)<br>* 6g sachet of maltodextrin, a complex carbohydrate. Each patient was instructed to consume two sachets per day, one in the morning and another before bedtime, diluted in 100 ml of filtered or boiled water at room temperature. Placebo should be taken daily for 6 months.<br>Behavioral: Nutritional intervention<br>* Nutritional intervention consists of dietary prescription (nutritional eating plan) for healthy eating based on the Dietary Guidelines for the Brazilian Population and Clinical Manual on Food and Nutrition in HIV-infected Adults Care, both Brazil Ministry of Health guidelines, in addition to nutritional counseling for preexistent clinical conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seric lipid levels | Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C. | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose | Changes from baseline in fasting blood glucose. | Baseline, Week 24 | 
| Gastrointestinal symptoms | 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. | Baseline, Week 24 | 
| Adherence to the nutritional intervention and nutritional appointments | Assessment of dietary intake modification after intervention and patient's return to nutritional appointments. | Baseline, Week 24 | 
| Body composition | 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. | Baseline, Week 24 | 
| Anthropometric measures | Changes from baseline in weight, waist circumference, abdominal circumference, waist-to-hip ratio and Body Mass Index (BMI). | Baseline, Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, diet therapy, symbiotic, dyslipidemia, gastrointestinal symptoms, body composition, adherence, HAART