Probiotics and the Gut Microbiome in Obese Hispanic Youth
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|ClinicalTrials.gov Identifier: NCT03115385|
Recruitment Status : Terminated (Funds ended.)
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity, Abdominal Adiposity||Dietary Supplement: VSL#3 Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Probiotics and the Gut Microbiome in Obese Hispanic Youth|
|Actual Study Start Date :||May 30, 2015|
|Actual Primary Completion Date :||April 11, 2016|
|Actual Study Completion Date :||April 11, 2016|
Placebo Comparator: Placebo
Inactive ingredients include maltose, lemon flavoring (or corn starch if unflavored), and silicon dioxide.
Dietary Supplement: Placebo
A matched placebo to VSL#3 will be provided. The placebo will be identical to the active VSL#3 probiotic in aspects such as packaging, color, taste, texture, shape, and odor. The placebo will not contain active ingredients. The study team will supply each participant with all necessary packets on a weekly or bi-weekly basis within 1-2 weeks after their first visit. The placebo is provided in powder form and needs to be mixed with liquid for consumption. For this reason, the study team will also provide participants with zero calorie sugar fee beverages to mix their packet with (e.g., vitamin water zero).
Active Comparator: VSL#3
VSL#3 is classified as a medical food that is specially formulated and processed to provide a precise mixture of 8 strains of bacterial species with potential synergistic relationships. These strains include Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, and Lactobacillus delbrueckii subsp. bulgaricus.
Dietary Supplement: VSL#3
VSL#3 will provide active packets. Subjects will take 2 to 3 packets per day with for 16 weeks. The study team will supply each participant with all necessary packets on a weekly or bi-weekly basis within 1-2 weeks after their first visit. VSL#3 probiotic is provided in powder form and needs to be mixed with cold, non-fizzy liquid for consumption. For this reason, the study team will also provide participants with zero calorie sugar fee beverages to mix their packet with (e.g., vitamin water zero with stevia).
- Change in abundance of gut microbiome and gut hormones measured pre and post blood and stool sample collections. [ Time Frame: 16 weeks ]To determine whether probiotic (VSL#3) supplementation affects gut microbiome and gut hormones involved with appetite regulation in obese young Hispanics.
- Interaction between gut microbiome and liver fat, fibrosis, obesity, and glycemia measured pre and post blood and stool sample collections and through Dxa and MRI scans.. [ Time Frame: 16 weeks ]To determine whether there are any relationships between changes in the gut microbiome and changes in liver fat, fibrosis, obesity, and glycemia after 16 weeks of probiotic supplementation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115385
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Michael I Goran, PhD||University of Southern California|