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Morbid ObesityNCT02660333

Effect of Prebiotic or Synbiotic on Inflammatory Response and Indicators of Nutritional Status in Obesity

A study testing Prebiotic and Synbiotic in people with Morbid Obesity, run by Universidade Federal de Santa Catarina at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the effect of prebiotic or synbiotic supplementation on inflammatory response and indicators of nutritional status in patients with morbid obesity. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Morbid Obesity
What is being tested?
Prebiotic and Synbiotic
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
1 siteBrazil
Study dates
Jan 2016to Apr 2018
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age greater than 18 years and less than 60 years
  • Body mass index (BMI)≥40kg/m2

Who cannot join

  • Previous gastrointestinal diseases (e.g. cancer and inflammatory bowel disease)
  • Intolerances and/or food allergies (e.g. lactose intolerance and celiac disease)
  • Current use of anti-inflammatory drugs and/or antibiotics and/or immunosuppressants
  • Regular use of laxatives and/or appetite suppressants
  • Current or previous use (up to one month) of prebiotics, probiotics, synbiotics or products enriched with these food compounds
  • Intolerance to prebiotic and/or probiotic and/or synbiotic
Show all 11Show fewer
  • Following a diet for weight loss in the last three months
  • Pregnant or breastfeeding
  • Following unusual diets (e.g. vegetarian, macrobiotic)
  • Alcohol dependence and/or illicit drugs dependence
  • Smokers

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Polydoro Ernani de São Thiago University Hospital

    Florianópolis, Santa Catarina, 88040900

Other trials in Brazil

About this study

Official title: Effect of Prebiotic or Synbiotic Supplementation on Inflammatory Response and Indicators of Nutritional Status in Individuals With Morbid Obesity: A Randomized Clinical Trial, Placebo-controlled and Triple Blind

The purpose of this study is to evaluate the effect of prebiotic or synbiotic supplementation on inflammatory response and indicators of nutritional status in patients with morbid obesity. Study hypothesis: Supplementation of 12 g/day of fructooligosaccharides (prebiotic) or 12 g/day of fructooligosaccharides + strains of lactobacilli and bifidobacteria (synbiotic) during 30 days promotes reduction of plasma/serum levels of acute phase proteins, cytokines, metabolic and anthropometric parameters in individuals with BMI ≥ 40kg/m².

Read the detailed description

The purpose of this study is to evaluate the effect of prebiotic or synbiotic supplementation on inflammatory response and indicators of nutritional status in patients with morbid obesity. Adult individuals of both sexes with morbid obesity (body mass index ≥ 40 kg/m²) will be invited to participate in this randomized, placebo-controlled, triple-blind study. The participants will be divided into three groups: G1 - control group (placebo), G2 - prebiotic group and G3 - synbiotic group. The study will consist of four experimental time points: M0 - baseline and start of supplementation; M1 - after fifteen days of the first outpatient visit and fifteen days after the start of supplementation with prebiotic, synbiotic or placebo; M2 - after thirty days from the first outpatient visit and end of supplementation with prebiotic, synbiotic and placebo; and M3 - time after sixty days from the first outpatient visit. At all time points the inflammatory response will be assessed by determination of plasma cytokines (IL-1, IL-6, IL-10, TNF) and acute phase proteins (c-reactive protein and albumin), besides the evaluation of laboratory and anthropometric indicators of nutritional status. The primary endpoint will be the reduction in concentrations of inflammatory markers (cytokines and acute phase proteins).

Investigators expect to contribute with new information in this field of knowledge, which may facilitate the clinical application of these results.

Conditions
Morbid Obesity
Being tested
Placebo, Prebiotic, Synbiotic
Keywords
Obesity, Inflammation, Nutritional status, Prebiotic, Synbiotic
Medical subject headings
Obesity, Morbid, Obesity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    Maltodextrin - 11g/day

  • PrebioticDietary supplement

    Fructooligosaccharide - 11g/day

  • SynbioticDietary supplement

    Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019 - 11g/day

Study groups in NCT02660333
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMaltodextrin
Receives: Dietary Supplement: Placebo
PrebioticActive comparatorFructooligosaccharide
Receives: Dietary Supplement: Prebiotic
SynbioticActive comparatorFructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019
Receives: Dietary Supplement: Synbiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. C-reactive protein

    Serum C-reactive protein concentrations (mg/L)

    Measured: 2 months

  2. Cytokines

    Plasma IL-1, IL-6, IL-8, IL-10, IL-12p70 and TNF-alpha concentrations (pg/mL)

    Measured: 2 months

Secondary outcomes (27)

  1. Triglycerides

    Serum concentrations of triglycerides (mg/dL)

    Measured: 2 months

  2. Total cholesterol

    Serum concentrations of total cholesterol (mg/dL)

    Measured: 2 months

  3. LDL-c

    Serum concentrations of LDL-cholesterol (mg/dL)

    Measured: 2 months

  4. HDL-c

    Serum concentrations of HDL-cholesterol (mg/dL)

    Measured: 2 months

  5. Blood glucose

    Blood glucose concentrations (mg/dL)

    Measured: 2 months

  6. Glycated hemoglobin

    Blood concentrations of glycated hemoglobin (%)

    Measured: 2 months

  7. Growth hormone

    Serum concentrations of Growth hormone (ng/mL)

    Measured: 2 months

  8. Fasting insulin

    Serum concentrations of insulin (IU/mL)

    Measured: 2 months

  9. Calcium

    Serum concentrations of calcium (mg/dL)

    Measured: 2 months

  10. Iron

    Serum concentrations of iron (mg/dL)

    Measured: 2 months

  11. Sodium

    Serum concentrations of sodium (mEq/L)

    Measured: 2 months

  12. Potassium

    Serum concentrations of potassium (mEq/L)

    Measured: 2 months

  13. Phosphorus

    Serum concentrations of phosphorus(mg/dL)

    Measured: 2 months

  14. Folic acid

    Serum concentrations of folic acid (ng/mL)

    Measured: 2 months

  15. Vitamin B12

    Serum concentrations of vitamin B12 (pg/mL)

    Measured: 2 months

  16. Vitamin D

    Serum concentrations of vitamin D (ng/dL)

    Measured: 2 months

  17. Body weight

    Body weight (kg)

    Measured: 2 months

  18. Waist circumference

    Waist circumference (cm)

    Measured: 2 months

  19. Body mass index

    Body mass index (kg/m²)

    Measured: 2 months

  20. Brain-derived neurotrophic factor (BDNF)

    Plasma Brain-derived neurotrophic factor (ng or pg/mL)

    Measured: 2 months

  21. Cortisol

    Plasma cortisol (ug/dL)

    Measured: 2 months

  22. Leptin

    Plasma leptin (ng/mL)

    Measured: 2 months

  23. Ghrelin

    Plasma ghrelin (pg/mL)

    Measured: 2 months

  24. Adrenocorticotropic Hormone (ACTH)

    Plasma Adrenocorticotropic Hormone (pg/mL)

    Measured: 2 months

  25. Hepcidin

    Hepcidin (ng/mL)

    Measured: 2 months

  26. Parathormone (PTH)

    Parathormone (ng/mL)

    Measured: 2 months

  27. Thyroid-Stimulating Hormone (TSH)

    Thyroid-Stimulating Hormone (µIU/mL)

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionFeb 2018
  4. Study completionApr 2018

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02660333
Sponsor's protocol ID
UFSC
Status last verified
Sep 2018
First submitted
14 Jan 2016
Last updated
2 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Prebiotic and Synbiotic in people with Morbid Obesity, run by Universidade Federal de Santa Catarina 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 2 inclusion and 11 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 2 Oct 2018. 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?

C-reactive protein (time frame: 2 months). The study lists 2 primary outcomes in all. 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 NCT02660333.

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 2 Oct 2018.

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