Synbiotics and Low Grade Inflammation in Obese Subjects

NCT01235026 | Unknown DMC

• 1 other identifier: Fondecyt-1080519
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the daily administration of a synbiotic (oligofructose and Bifidobacterium animalis subsp. lactis Bb12) for six weeks contributes to improve the glucose tolerance and the low grade inflammation (as reflected as the plasmatic concentrations of ultrasensitive CRP, IL-6, sCD14 and LPS-binding protein) in obese subjects.

Conditions

Obesity; Diabetes Mellitus Type-2; Insulin Resistance; Metabolic Syndrome

Keywords

Obesity; Type-2 Diabetes; Metabolic syndrome; Low grade inflammation; Metabolic endotoxinemia; Insulin resistance; Lipopolysaccharide; LPS-binding protein; sCD14; Synbiotic; Oligofructose; Bifidobacterium animalis subsp. lactis Bb12; probiotic; Prebiotic

Outcome Measures

Primary Outcomes (1)

• Plasmatic Interleukin-6 (IL-6)

  Plasmatic IL-6 will be determined after 6 weeks of administration of the synbiotic and compared with the IL-6 values at baseline.

  6 weeks

Secondary Outcomes (11)

• Plasmatic LPS-binding protein

  6 weeks

• Plasmatic sCD14

  6 weeks

• glucose tolerance curve

  6 weeks

• Lipid profile

  6 weeks

• plasmatic ultrasensitive C-Reactive Protein

  6 weeks

Study Arms (2)

Synbiotic

EXPERIMENTAL

Dietary Supplement: Synbiotic: combination of the prebiotic "Oligofructose" with the probiotic "Bifidobacterium animalis subsp. lactis Bb12"

Dietary Supplement: Synbiotic

Placebo

PLACEBO COMPARATOR

Dietary supplement: placebo: maltodextrin

Dietary Supplement: Placebo

Interventions

Synbiotic DIETARY_SUPPLEMENT

5g of the prebiotic "Oligofructose" + 1 g of the probiotic "Bifidobacterium animalis subsp. lactis Bb12" (4x10\^10 CFU/g), twice a day, for 6 weeks.

Synbiotic

Placebo DIETARY_SUPPLEMENT

6g of maltodextrin, twice a day for 6 weeks.

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI \> 30
• Non-smokers

You may not qualify if:

• Current digestive diseases or antecedents of chronic digestive diseases and/or malabsorption (celiac disease, Inflammatory bowel diseases, gastroduodenal ulcers, digestive malignancies, etc)
• Use of drugs that could interfere with the intestinal microbiota or with the integrity of the gut barrier function (antibiotics, anti-inflammatory drugs, laxatives, prokinetics, etc.) during the three weeks preceding the start the study
• Treatments (medication or nutritional program) affecting body weight or glucose control
• Basal glycemia\>130mg/dl (evaluated with glucose-meter)
• Immunodeficiencies (HIV, chemotherapy, radiotherapy, organ transplant).
• Current participation or recent previous having participation in another clinical trial.
• Pregnant or breastfeeding women.
• Consumption of probiotic products
• Drug or alcohol abuse

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Institute of Nutrition and Food Technology (INTA), University of Chile

Santiago, Chile

RECRUITING

Related Publications (5)

• Cani PD, Bibiloni R, Knauf C, Waget A, Neyrinck AM, Delzenne NM, Burcelin R. Changes in gut microbiota control metabolic endotoxemia-induced inflammation in high-fat diet-induced obesity and diabetes in mice. Diabetes. 2008 Jun;57(6):1470-81. doi: 10.2337/db07-1403. Epub 2008 Feb 27.

  PMID: 18305141 BACKGROUND

• Cani PD, Neyrinck AM, Fava F, Knauf C, Burcelin RG, Tuohy KM, Gibson GR, Delzenne NM. Selective increases of bifidobacteria in gut microflora improve high-fat-diet-induced diabetes in mice through a mechanism associated with endotoxaemia. Diabetologia. 2007 Nov;50(11):2374-83. doi: 10.1007/s00125-007-0791-0. Epub 2007 Sep 6.

  PMID: 17823788 BACKGROUND

• Ley RE, Turnbaugh PJ, Klein S, Gordon JI. Microbial ecology: human gut microbes associated with obesity. Nature. 2006 Dec 21;444(7122):1022-3. doi: 10.1038/4441022a.

  PMID: 17183309 BACKGROUND

• Wright SD, Ramos RA, Tobias PS, Ulevitch RJ, Mathison JC. CD14, a receptor for complexes of lipopolysaccharide (LPS) and LPS binding protein. Science. 1990 Sep 21;249(4975):1431-3. doi: 10.1126/science.1698311.

  PMID: 1698311 BACKGROUND

• Brunser O, Figueroa G, Gotteland M, Haschke-Becher E, Magliola C, Rochat F, Cruchet S, Palframan R, Gibson G, Chauffard F, Haschke F. Effects of probiotic or prebiotic supplemented milk formulas on fecal microbiota composition of infants. Asia Pac J Clin Nutr. 2006;15(3):368-76.

  PMID: 16837430 BACKGROUND

MeSH Terms

Conditions

Obesity; Insulin Resistance; Metabolic Syndrome

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Central Study Contacts

Martin Gotteland, PhD

CONTACT

56-2-9781471; mgottela@inta.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 5, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: December 17, 2010

Record last verified: 2010-10

Locations

CL (1)