Obesity, Childhood
Conditions
Brief summary
This study evaluates the feasibility and effect of probiotics on glycemic control in obese adolescents.
Detailed description
Diet-induced intestinal dysbiosis in obese children contributes to the development of type 2 diabetes mellitus (T2D). Probiotic treatment has been proposed to alleviate glycemic dysfunction and prevent/delay development of T2D. The investigators will test probiotics to improve insulin sensitivity and preserve beta cell function in obese children. The probiotic strains are known to improve glycemic control.
Interventions
DIETARY_SUPPLEMENTVivomixx
900 billion of the following probiotic strains: L. acidophilus DSM24735; L. plantarum DSM24730; L. paracasei DSM24733; L. delbrueckii supsp. bulgaricus DSM24734, S. thermophilus DSM24731, B. longum DSM24736, B. breve DSM24732, and B. infantis DSM24737) maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)
DIETARY_SUPPLEMENTPlacebo
maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)
Sponsors
University of Washington
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The study product will be prepackaged and will be supplied and labeled only with the Protocol Number.
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, 13-19 y. of age at Visit 1. * BMI: 99th percentile or greater * Acanthosis nigricans * Pubertal Tanner stage ≥3
Exclusion criteria
* Secondary diabetes (i.e. post-transplant diabetes mellitus (DM) or cystic fibrosis DM), monogenic forms of diabetes (i.e. MODY), autoimmune diabetes or presence of islet autoantibodies. * Known severe immunodeficiency, or immune compromised. * Current or previous history for insulin or metformin therapy (within last 3 months). * Antibiotic or probiotic therapy 3 months prior to enrollment. * Start of new dietary intervention within 1 month prior to enrollment. * Diagnosed food hypersensitivity or active gastrointestinal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in microbiota composition | Baseline and 12 weeks | Microbiome (16S rRNA) analysis, fecal immunoglobulin (Ig)A |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin resistance | baseline and 12 weeks | Measures of homeostatic model assessment of insulin resistance (HOMA-IR) |
| Change in inflammation in blood | baseline and 12 weeks | measures of high sensitive cardio-reactive protein (hsCRP) |
| Change in inflammation in the gut | baseline and 12 weeks | measure of fecal calprotectin |
Countries
United States
Outcome results
None listed