Dietary Modification, Dyslipidemia, HIV, Signs and Symptoms, Digestive
Conditions
Keywords
diet therapy, symbiotic, dyslipidemia, gastrointestinal symptoms, body composition, adherence, HIV, HAART
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).
Interventions
DIETARY_SUPPLEMENTSymbiotic
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.
DIETARY_SUPPLEMENTMaltodextrin (placebo for symbiotic)
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.
BEHAVIORALNutritional intervention
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.
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-infected patients * Adults (≥ 19 years old) * On highly active antiretroviral therapy (HAART)
Exclusion criteria
* Pregnancy * Breastfeeding * Opportunistic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seric lipid levels | Baseline, Week 24 | Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting blood glucose | Baseline, Week 24 | Changes from baseline in fasting blood glucose. |
| 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. |
| 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. |
| 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). |
Countries
Brazil
Outcome results
None listed