The Effects of Dietary Fiber on the Gut Microbiome and HDL Particles of Human Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03785860|
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : November 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gut Microbiota||Other: Dietary Fiber Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effects of Dietary Fiber on the Gut Microbiome and HDL Particles of Human Subjects|
|Actual Study Start Date :||May 13, 2019|
|Estimated Primary Completion Date :||December 20, 2019|
|Estimated Study Completion Date :||December 20, 2019|
Placebo Comparator: Placebo
On the Placebo arm of the intervention, participants will consume a placebo powder.
Placebo will be given in a powder form to mix with a beverage of one's choice.
Active Comparator: Dietary Fiber
On the Dietary Fiber arm of the intervention, participants will consume a fiber powder.
Other: Dietary Fiber
Dietary fiber will be given in a powder form to mix with a beverage of one's choice.
- Change in gut microbiota [ Time Frame: One month time frame for dietary fiber to affect the gut microbiota of participants ]Gene sequencing and data analysis will be conducted to explore the change in gut microbial abundance and diversity. Specifically, the primary outcome measure will be change in the proportion of Bifidobacterium, Lactobacillus, and/or Akkermansia muciniphila.
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): NCT03785860
|Contact: Jea Woo Kang||(530) firstname.lastname@example.org|
|United States, California|
|University of California, Davis Department of Nutrition||Recruiting|
|Davis, California, United States, 95616|
|Contact: Jea Woo Kang 530-752-3973 email@example.com|
|Principal Investigator: Angela Zivkovic, PhD|