- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02660333
Effect of Prebiotic or Synbiotic on Inflammatory Response and Indicators of Nutritional Status in Obesity
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
SC
-
Florianópolis, SC, Brasil, 88040900
- Polydoro Ernani de São Thiago University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age greater than 18 years and less than 60 years
- Body mass index (BMI)≥40kg/m2
Exclusion Criteria:
- 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
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Placebo
Maltodekstrin
|
Maltodextrin - 11g/day
|
Aktiv komparator: Prebiotic
Fructooligosaccharide
|
Fructooligosaccharide - 11g/day
|
Aktiv komparator: Synbiotic
Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019
|
Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019 - 11g/day
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
C-reactive protein
Tidsramme: 2 months
|
Serum C-reactive protein concentrations (mg/L)
|
2 months
|
Cytokines
Tidsramme: 2 months
|
Plasma IL-1, IL-6, IL-8, IL-10, IL-12p70 and TNF-alpha concentrations (pg/mL)
|
2 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Triglycerides
Tidsramme: 2 months
|
Serum concentrations of triglycerides (mg/dL)
|
2 months
|
Total cholesterol
Tidsramme: 2 months
|
Serum concentrations of total cholesterol (mg/dL)
|
2 months
|
LDL-c
Tidsramme: 2 months
|
Serum concentrations of LDL-cholesterol (mg/dL)
|
2 months
|
HDL-c
Tidsramme: 2 months
|
Serum concentrations of HDL-cholesterol (mg/dL)
|
2 months
|
Blood glucose
Tidsramme: 2 months
|
Blood glucose concentrations (mg/dL)
|
2 months
|
Glycated hemoglobin
Tidsramme: 2 months
|
Blood concentrations of glycated hemoglobin (%)
|
2 months
|
Growth hormone
Tidsramme: 2 months
|
Serum concentrations of Growth hormone (ng/mL)
|
2 months
|
Fasting insulin
Tidsramme: 2 months
|
Serum concentrations of insulin (IU/mL)
|
2 months
|
Calcium
Tidsramme: 2 months
|
Serum concentrations of calcium (mg/dL)
|
2 months
|
Iron
Tidsramme: 2 months
|
Serum concentrations of iron (mg/dL)
|
2 months
|
Sodium
Tidsramme: 2 months
|
Serum concentrations of sodium (mEq/L)
|
2 months
|
Potassium
Tidsramme: 2 months
|
Serum concentrations of potassium (mEq/L)
|
2 months
|
Phosphorus
Tidsramme: 2 months
|
Serum concentrations of phosphorus(mg/dL)
|
2 months
|
Folic acid
Tidsramme: 2 months
|
Serum concentrations of folic acid (ng/mL)
|
2 months
|
Vitamin B12
Tidsramme: 2 months
|
Serum concentrations of vitamin B12 (pg/mL)
|
2 months
|
Vitamin D
Tidsramme: 2 months
|
Serum concentrations of vitamin D (ng/dL)
|
2 months
|
Body weight
Tidsramme: 2 months
|
Body weight (kg)
|
2 months
|
Waist circumference
Tidsramme: 2 months
|
Waist circumference (cm)
|
2 months
|
Body mass index
Tidsramme: 2 months
|
Body mass index (kg/m²)
|
2 months
|
Brain-derived neurotrophic factor (BDNF)
Tidsramme: 2 months
|
Plasma Brain-derived neurotrophic factor (ng or pg/mL)
|
2 months
|
Cortisol
Tidsramme: 2 months
|
Plasma cortisol (ug/dL)
|
2 months
|
Leptin
Tidsramme: 2 months
|
Plasma leptin (ng/mL)
|
2 months
|
Ghrelin
Tidsramme: 2 months
|
Plasma ghrelin (pg/mL)
|
2 months
|
Adrenocorticotropic Hormone (ACTH)
Tidsramme: 2 months
|
Plasma Adrenocorticotropic Hormone (pg/mL)
|
2 months
|
Hepcidin
Tidsramme: 2 months
|
Hepcidin (ng/mL)
|
2 months
|
Parathormone (PTH)
Tidsramme: 2 months
|
Parathormone (ng/mL)
|
2 months
|
Thyroid-Stimulating Hormone (TSH)
Tidsramme: 2 months
|
Thyroid-Stimulating Hormone (µIU/mL)
|
2 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Erasmo Trindade, PhD, Federal University of Santa Catarina
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UFSC
Plan for individuelle deltakerdata (IPD)
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