Dietary ModificationPRECOR-NUTNCT02180035
Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS
A study testing Symbiotic and Nutritional intervention in people with Dietary Modification and Dyslipidemia, run by Conselho Nacional de Desenvolvimento Científico e Tecnológico at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dietary Modification, Dyslipidemia, Signs and Symptoms, Digestive
- What is being tested?
- Symbiotic and Nutritional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected patients
- Adults (≥ 19 years old)
- On highly active antiretroviral therapy (HAART)
Who cannot join
- Pregnancy
- Breastfeeding
- Opportunistic disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Outpatient Infectoparasitary Diseases, Hospital das Clinicas, Federal University of Goiás
Goiânia, Goiás, 74.605-020
About this study
Official title: Effect of Treatment Nutritional With Supplementation About Biochemical Profile and Anthropometry 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).
- Conditions
- Dietary Modification, Dyslipidemia, Signs and Symptoms, Digestive, HIV
- Being tested
- Symbiotic, Maltodextrin (placebo for symbiotic), Nutritional intervention
- Keywords
- diet therapy, symbiotic, dyslipidemia, gastrointestinal symptoms, body composition, adherence, HIV, HAART
- Medical subject headings
- Dyslipidemias, Signs and Symptoms, Digestive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymbioticDietary 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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Symbiotic & Nutritional intervention | Experimental | Symbiotic (dietary fibers + probiotic bacteria) 6g sachet twice daily for 6 months, dietary prescription and nutritional counseling Receives: Dietary Supplement: Symbiotic; Behavioral: Nutritional intervention |
| Maltodextrin & Nutritional intervention | Placebo comparator | Maltodextrin (placebo for symbiotic) 6g sachet twice daily for 6 months, dietary intervention and nutritional counseling. Receives: Dietary Supplement: Maltodextrin (placebo for symbiotic); Behavioral: Nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seric lipid levels
Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C.
Measured: Baseline, Week 24
Secondary outcomes (5)
Fasting blood glucose
Changes from baseline in fasting blood glucose.
Measured: Baseline, Week 24
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.
Measured: Baseline, Week 24
Adherence to the nutritional intervention and nutritional appointments
Assessment of dietary intake modification after intervention and patient's return to nutritional appointments.
Measured: Baseline, Week 24
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.
Measured: Baseline, Week 24
Anthropometric measures
Changes from baseline in weight, waist circumference, abdominal circumference, waist-to-hip ratio and Body Mass Index (BMI).
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startOct 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marianne de Oliveira Falco, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Marianne O Falco, MSc, Principal investigator, Federal University of GoiásErika A Silveira, PhD, Study director, Federal University of Goiás
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180035
- Sponsor's protocol ID
- CNPq- 478741/2008-1
- Acronym
- PRECOR-NUT
- Status last verified
- Jul 2014
- First submitted
- 1 Jul 2014
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22782126Nery 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.
PubMed 24228022Santos 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.
PubMed 27395330
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment Nutritional With Supplementation About Biochemical Profile and Anthropometry in Adult Patients With HIV/AIDS
- ClinicalTrials.gov ID
- NCT02180035
- Acronym / sponsor ID
- PRECOR-NUT / CNPq- 478741/2008-1
- Conditions
- Dietary Modification, Dyslipidemia, Signs and Symptoms, Digestive, HIV
- Keywords
- diet therapy, symbiotic, dyslipidemia, gastrointestinal symptoms, body composition, adherence, HIV, HAART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Conselho Nacional de Desenvolvimento Científico e TecnológicoOther government
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbiotic & Nutritional intervention | Experimental | Dietary Supplement: Symbiotic, Behavioral: Nutritional interventionSymbiotic (dietary fibers + probiotic bacteria) 6g sachet twice daily for 6 months, dietary prescription and nutritional counseling |
| Maltodextrin & Nutritional intervention | Placebo comparator | Dietary Supplement: Maltodextrin (placebo for symbiotic), Behavioral: Nutritional interventionMaltodextrin (placebo for symbiotic) 6g sachet twice daily for 6 months, dietary intervention and nutritional counseling. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-infected patients
- Adults (≥ 19 years old)
- On highly active antiretroviral therapy (HAART)
Key exclusion criteria (3 listed)
- Pregnancy
- Breastfeeding
- Opportunistic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symbiotic6g 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. | Dietary supplement | Symbiotic & Nutritional intervention |
| 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. | Dietary supplement | Maltodextrin & Nutritional intervention |
| Nutritional interventionNutritional 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. | Behavioural | Maltodextrin & Nutritional intervention, Symbiotic & Nutritional intervention |
Primary outcome
Seric lipid levels
Time frame: Baseline, Week 24
Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C.
5 secondary outcomes
Fasting blood glucose
Time frame: Baseline, Week 24
Gastrointestinal symptoms
Time frame: Baseline, Week 24
Adherence to the nutritional intervention and nutritional appointments
Time frame: Baseline, Week 24
Body composition
Time frame: Baseline, Week 24
Anthropometric measures
Time frame: Baseline, Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
- Background: PubMed 22782126Falco 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.
- Background: PubMed 24228022Nery 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.
- Derived from this study: PubMed 27395330Santos 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.
- Brazil Ministry of Health guidance on food and nutrition for patients with HIVLink provided by the sponsor.
Related trials for Dietary Modification
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne O Falco, MSc principal investigator
Federal University of Goiás
Erika A Silveira, PhD study director
Federal University of Goiás
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symbiotic and Nutritional intervention in people with Dietary Modification and Dyslipidemia, run by Conselho Nacional de Desenvolvimento Científico e Tecnológico at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seric lipid levels (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180035, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.