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

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ClinicalTrials.gov Identifier: NCT02180035
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : July 17, 2014
Sponsor:
Information provided by (Responsible Party):
Marianne de Oliveira Falco, Conselho Nacional de Desenvolvimento Científico e Tecnológico

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).

Condition or disease Intervention/treatment Phase
Dietary Modification Dyslipidemia Signs and Symptoms, Digestive HIV Dietary Supplement: Symbiotic Dietary Supplement: Maltodextrin (placebo for symbiotic) Behavioral: Nutritional intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Treatment Nutritional With Supplementation About Biochemical Profile and Anthropometry in Adult Patients With HIV/AIDS
Study Start Date : October 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Symbiotic & Nutritional intervention
Symbiotic (dietary fibers + probiotic bacteria) 6g sachet twice daily for 6 months, dietary prescription and nutritional counseling
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.

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.

Placebo Comparator: Maltodextrin & Nutritional intervention
Maltodextrin (placebo for symbiotic) 6g sachet twice daily for 6 months, dietary intervention and nutritional counseling.
Dietary Supplement: 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.




Primary Outcome Measures :
  1. Seric lipid levels [ Time Frame: Baseline, Week 24 ]
    Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C.


Secondary Outcome Measures :
  1. Fasting blood glucose [ Time Frame: Baseline, Week 24 ]
    Changes from baseline in fasting blood glucose.

  2. Gastrointestinal symptoms [ Time Frame: Baseline, Week 24 ]
    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.

  3. Adherence to the nutritional intervention and nutritional appointments [ Time Frame: Baseline, Week 24 ]
    Assessment of dietary intake modification after intervention and patient's return to nutritional appointments.

  4. Body composition [ Time Frame: Baseline, Week 24 ]
    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.

  5. Anthropometric measures [ Time Frame: Baseline, Week 24 ]
    Changes from baseline in weight, waist circumference, abdominal circumference, waist-to-hip ratio and Body Mass Index (BMI).



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Opportunistic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180035


Locations
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Brazil
Outpatient Infectoparasitary Diseases, Hospital das Clinicas, Federal University of Goiás
Goiânia, Goiás, Brazil, 74.605-020
Sponsors and Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Marianne O Falco, MSc Federal University of Goiás
Study Director: Erika A Silveira, PhD Federal University of Goiás

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marianne de Oliveira Falco, Effect of Treatment With Nutritional Eating Plan and Supplementation With Dietary Fibers in Adult Patients With HIV / AIDS, Conselho Nacional de Desenvolvimento Científico e Tecnológico
ClinicalTrials.gov Identifier: NCT02180035     History of Changes
Other Study ID Numbers: CNPq- 478741/2008-1
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: July 17, 2014
Last Verified: July 2014
Keywords provided by Marianne de Oliveira Falco, Conselho Nacional de Desenvolvimento Científico e Tecnológico:
diet therapy
symbiotic
dyslipidemia
gastrointestinal symptoms
body composition
adherence
HIV
HAART
Additional relevant MeSH terms:
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Dyslipidemias
Signs and Symptoms, Digestive
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases