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Completed

NCT Number: NCT02180035

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

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).

Completed

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Key information

Conditions

Dietary Modification Dyslipidemia Dyslipidemias HIV Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Goiânia, Goiás, 74.605-020, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Breastfeeding
  • Opportunistic disease

Treatment and study plan

Symbiotic

Dietary Supplement

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)

Dietary Supplement

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

Behavioral

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 outcomes

  1. Seric lipid levels

    Time frame: Baseline, Week 24

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

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Other Gov

Registry information

Official study title

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

Acronym: PRECOR-NUT

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 2, 2014
Registry last updated
Jul 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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