Sponsor study identifier
interventional
290
1 country
1
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
July 2011
Actual (reported)July 2011
Actual (reported)July 1, 2014
Actual (reported)July 2, 2014
Actual (reported)Seric lipid levels
Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C.
Baseline, Week 24
Fasting blood glucose
Baseline, Week 24
Gastrointestinal symptoms
Baseline, Week 24
Adherence to the nutritional intervention and nutritional appointments
Symbiotic (dietary fibers + probiotic bacteria) 6g sachet twice daily for 6 months, dietary prescription and nutritional counseling
Maltodextrin (placebo for symbiotic) 6g sachet twice daily for 6 months, dietary intervention and nutritional counseling.
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.
Outpatient Infectoparasitary Diseases, Hospital das Clinicas, Federal University of Goiás
Goiânia, Goiás, 74.605-020, Brazil
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.
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.
Marianne O Falco, MSc
Federal University of Goiás
Erika A Silveira, PhD
Federal University of Goiás
290 participants (actual enrollment reported by the registry).
First Submitted
July 1, 2014
First Posted
July 2, 2014
Study Start
October 2009
Date type not reportedBaseline, Week 24
Body composition
Baseline, Week 24
Anthropometric measures
Baseline, Week 24
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 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
This date has not been verified as actual or estimated.
Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)Last Updated
July 17, 2014
Record last verified: 2014-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: