Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS

HIV Clinical Trial

— PRECOR-NUT  

Official title:

Effect of Treatment Nutritional With Supplementation About Biochemical Profile and Anthropometry in Adult Patients With HIV/AIDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180035
• Other study ID #: CNPq- 478741/2008-1
• 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
• 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

Related Conditions & MeSH terms

• Dietary Modification
• Dyslipidemia
• Dyslipidemias
• HIV
• Signs and Symptoms
• Signs and Symptoms, Digestive

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

External Links

•   Brazil Ministry of Health guidance on food and nutrition for patients with HIV