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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02180035
Other study ID # CNPq- 478741/2008-1
Secondary ID
Status Completed
Phase N/A
First received July 1, 2014
Last updated July 16, 2014
Start date October 2009
Est. completion date July 2011

Study information

Verified date July 2014
Source Conselho Nacional de Desenvolvimento Científico e Tecnológico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 290
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- HIV-infected patients

- Adults (= 19 years old)

- On highly active antiretroviral therapy (HAART)

Exclusion Criteria:

- Pregnancy

- Breastfeeding

- Opportunistic disease

Study Design


Intervention

Dietary Supplement:
Symbiotic
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.
Maltodextrin (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.
Behavioral:
Nutritional 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.

Locations

Country Name City State
Brazil Outpatient Infectoparasitary Diseases, Hospital das Clinicas, Federal University of Goiás Goiânia Goiás

Sponsors (1)

Lead Sponsor Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. Epub 2012 Jul 10. Review. Portuguese. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Seric lipid levels Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C. Baseline, Week 24
Secondary Fasting blood glucose Changes from baseline in fasting blood glucose. Baseline, Week 24
Secondary 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. Baseline, Week 24
Secondary 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
Secondary 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
Secondary Anthropometric measures Changes from baseline in weight, waist circumference, abdominal circumference, waist-to-hip ratio and Body Mass Index (BMI). Baseline, Week 24
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