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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
290
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.
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.
Outpatient Infectoparasitary Diseases, Hospital das Clinicas, Federal University of Goiás
Goiânia, Goiás, Brazil
Seric lipid levels
Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C.
Time frame: Baseline, Week 24
Fasting blood glucose
Changes from baseline in fasting blood glucose.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 24
Anthropometric measures
Changes from baseline in weight, waist circumference, abdominal circumference, waist-to-hip ratio and Body Mass Index (BMI).
Time frame: Baseline, Week 24
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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.