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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symbiotic & Nutritional intervention | Experimental | Symbiotic (dietary fibers + probiotic bacteria) 6g sachet twice daily for 6 months, dietary prescription and nutritional counseling |
|
| Maltodextrin & Nutritional intervention | Placebo Comparator | Maltodextrin (placebo for symbiotic) 6g sachet twice daily for 6 months, dietary intervention and nutritional counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbiotic | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Seric lipid levels | Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C. | Baseline, Week 24 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne O Falco, MSc | Federal University of Goiás | Principal Investigator |
| Erika A Silveira, PhD | Federal University of Goiás | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient Infectoparasitary Diseases, Hospital das Clinicas, Federal University of Goiás | Goiânia | Goiás | 74.605-020 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22782126 | Background | Falco M, Castro Ade C, Silveira EA. [Nutritional therapy in metabolic changes in individuals with HIV/AIDS]. Rev Saude Publica. 2012 Aug;46(4):737-46. doi: 10.1590/s0034-89102012005000050. Epub 2012 Jul 10. Portuguese. | |
| 24228022 | Background | Nery MW, Martelli CM, Silveira EA, de Sousa CA, Falco Mde O, de Castro Ade C, Esper JT, Souza LC, Turchi MD. Cardiovascular risk assessment: a comparison of the Framingham, PROCAM, and DAD equations in HIV-infected persons. ScientificWorldJournal. 2013 Oct 21;2013:969281. doi: 10.1155/2013/969281. eCollection 2013. |
| Label | URL |
|---|---|
| Brazil Ministry of Health guidance on food and nutrition for patients with HIV | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 22, 2015 | |
| Unrelease | Yes | |
| Release | May 23, 2015 |
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|
| Maltodextrin (placebo for symbiotic) | Dietary Supplement | 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. |
|
| Nutritional intervention | Behavioral | 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. |
|
| 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 |
| 27395330 | Derived | Santos ASEAC, Silveira EAD, Falco MO, Nery MW, Turchi MD. Effectiveness of nutritional treatment and synbiotic use on gastrointestinal symptoms reduction in HIV-infected patients: Randomized clinical trial. Clin Nutr. 2017 Jun;36(3):680-685. doi: 10.1016/j.clnu.2016.06.005. Epub 2016 Jun 23. |
| Reset | Jun 15, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 22, 2015 | Yes | |||
| May 23, 2015 | Jun 15, 2015 |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D012817 | Signs and Symptoms, Digestive |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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