Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS
PRECOR-NUT
Effect of Treatment Nutritional With Supplementation About Biochemical Profile and Anthropometry in Adult Patients With HIV/AIDS
1 other identifier
interventional
290
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 2, 2014
CompletedJuly 17, 2014
July 1, 2014
1.7 years
July 1, 2014
July 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seric lipid levels
Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C.
Baseline, Week 24
Secondary Outcomes (5)
Fasting blood glucose
Baseline, Week 24
Gastrointestinal symptoms
Baseline, Week 24
Adherence to the nutritional intervention and nutritional appointments
Baseline, Week 24
Body composition
Baseline, Week 24
Anthropometric measures
Baseline, Week 24
Study Arms (2)
Symbiotic & Nutritional intervention
EXPERIMENTALSymbiotic (dietary fibers + probiotic bacteria) 6g sachet twice daily for 6 months, dietary prescription and nutritional counseling
Maltodextrin & Nutritional intervention
PLACEBO COMPARATORMaltodextrin (placebo for symbiotic) 6g sachet twice daily for 6 months, dietary intervention and nutritional counseling.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- HIV-infected patients
- Adults (≥ 19 years old)
- On highly active antiretroviral therapy (HAART)
You may not qualify if:
- Pregnancy
- Breastfeeding
- Opportunistic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Outpatient Infectoparasitary Diseases, Hospital das Clinicas, Federal University of Goiás
Goiânia, Goiás, 74.605-020, Brazil
Related Publications (3)
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.
PMID: 22782126BACKGROUNDNery 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.
PMID: 24228022BACKGROUNDSantos 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.
PMID: 27395330DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marianne O Falco, MSc
Federal University of Goiás
- STUDY DIRECTOR
Erika A Silveira, PhD
Federal University of Goiás
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Effect of Treatment With Nutritional Eating Plan and Supplementation With Dietary Fibers in Adult Patients With HIV / AIDS
Study Record Dates
First Submitted
July 1, 2014
First Posted
July 2, 2014
Study Start
October 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
July 17, 2014
Record last verified: 2014-07