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Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS (PRECOR-NUT)

Primary Purpose

Dietary Modification, Dyslipidemia, Signs and Symptoms, Digestive

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Symbiotic
Maltodextrin (placebo for symbiotic)
Nutritional intervention
Sponsored by
Conselho Nacional de Desenvolvimento Científico e Tecnológico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dietary Modification focused on measuring diet therapy, symbiotic, dyslipidemia, gastrointestinal symptoms, body composition, adherence, HIV, HAART

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV-infected patients
  • Adults (≥ 19 years old)
  • On highly active antiretroviral therapy (HAART)

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Opportunistic disease

Sites / Locations

  • Outpatient Infectoparasitary Diseases, Hospital das Clinicas, Federal University of Goiás

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Symbiotic & Nutritional intervention

Maltodextrin & Nutritional intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Seric lipid levels
Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C.

Secondary Outcome Measures

Fasting blood glucose
Changes from baseline in fasting blood glucose.
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.
Adherence to the nutritional intervention and nutritional appointments
Assessment of dietary intake modification after intervention and patient's return to nutritional appointments.
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.
Anthropometric measures
Changes from baseline in weight, waist circumference, abdominal circumference, waist-to-hip ratio and Body Mass Index (BMI).

Full Information

First Posted
July 1, 2014
Last Updated
July 16, 2014
Sponsor
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02180035
Brief Title
Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS
Acronym
PRECOR-NUT
Official Title
Effect of Treatment Nutritional With Supplementation About Biochemical Profile and Anthropometry in Adult Patients With HIV/AIDS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Modification, Dyslipidemia, Signs and Symptoms, Digestive, HIV
Keywords
diet therapy, symbiotic, dyslipidemia, gastrointestinal symptoms, body composition, adherence, HIV, HAART

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symbiotic & Nutritional intervention
Arm Type
Experimental
Arm Description
Symbiotic (dietary fibers + probiotic bacteria) 6g sachet twice daily for 6 months, dietary prescription and nutritional counseling
Arm Title
Maltodextrin & Nutritional intervention
Arm Type
Placebo Comparator
Arm Description
Maltodextrin (placebo for symbiotic) 6g sachet twice daily for 6 months, dietary intervention and nutritional counseling.
Intervention Type
Dietary Supplement
Intervention Name(s)
Symbiotic
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin (placebo for symbiotic)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Seric lipid levels
Description
Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Fasting blood glucose
Description
Changes from baseline in fasting blood glucose.
Time Frame
Baseline, Week 24
Title
Gastrointestinal symptoms
Description
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.
Time Frame
Baseline, Week 24
Title
Adherence to the nutritional intervention and nutritional appointments
Description
Assessment of dietary intake modification after intervention and patient's return to nutritional appointments.
Time Frame
Baseline, Week 24
Title
Body composition
Description
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.
Time Frame
Baseline, Week 24
Title
Anthropometric measures
Description
Changes from baseline in weight, waist circumference, abdominal circumference, waist-to-hip ratio and Body Mass Index (BMI).
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-infected patients Adults (≥ 19 years old) On highly active antiretroviral therapy (HAART) Exclusion Criteria: Pregnancy Breastfeeding Opportunistic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne O Falco, MSc
Organizational Affiliation
Federal University of Goiás
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erika A Silveira, PhD
Organizational Affiliation
Federal University of Goiás
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient Infectoparasitary Diseases, Hospital das Clinicas, Federal University of Goiás
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74.605-020
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22782126
Citation
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.
Results Reference
background
PubMed Identifier
24228022
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.
Results Reference
background
PubMed Identifier
27395330
Citation
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.
Results Reference
derived
Links:
URL
http://189.28.128.100/nutricao/docs/geral/manual_clinico_alimentacao_nutricao_aids_hiv.pdf
Description
Brazil Ministry of Health guidance on food and nutrition for patients with HIV

Learn more about this trial

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

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