Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484504
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-07
Brief Title:
Effect of Kombucha Consumption on the Microbiome in Healthy Subjects
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Effect of Kombucha Consumption on the Microbiome in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KOMICS
Brief Summary:
This proposed pilot study will assess the ability of consumption of two servings of kombucha daily to decrease inflammation alter the gut microbiome composition and improve intestinal wellbeing in a free-living population The primary objective is to determine changes in the fecal microbiome composition Secondary outcomes will be bacterial metabolites fecal indole propionic acid calprotectin serum interleukin IL 6 interleukin IL 10 C-reactive protein CRP C-peptide insulin fasting glucose Homeostatic Model Assessment for Insulin Resistance HOMA 14-day continuous glucose monitor digestive health dietary information general Health Wellness at 4 and 8 weeks
Detailed Description:
An altered intestinal gut microbiota ie dysbiosis has been associated with the development of intestinal disease including inflammatory bowel disease and metabolic diseases such as obesity type 2 diabetes mellitus T2DM and cardiovascular disease Fermented foods such as Kefir Kombucha Miso and Kimchi contain potentially probiotic microorganisms The characteristic microbiome in kombucha includes several genera of acetic acid bacteria yeasts and lactic acid bacteria Interactions between bacteria and yeast species can lead to the generation of a wide range of metabolites with interesting bioactivities such as organic acids sugars phenolic compounds Kombucha produced from green and black tea contain many phenolic compounds which contribute to its antioxidant and anti-inflammatory activity and effect on the intestinal microbiota However there is a lack of intervention trials investigating the health benefits of fermented foods Therefore the investigators propose a human intervention study to assess if daily consumption of two servings of kombucha will alter the intestinal microbiota decrease inflammation and improve digestive health in a two-phase design in a free-living population
This will be a randomized controlled two arm intervention study The study will be conducted in 30 healthy free-living subjects 21-55 years After 4-weeks of consuming a beige diet ie low-fiber low polyphenol diet 20 subjects will consume one bottle two servings of kombucha daily for 4 weeks and 10 subjects will not change their dietary habits At baseline week 0 week 4 and 8 blood will be collected On the day prior to the study visits at week 4 and 8 participants will collect a stool and bring it to the lab On the day of study visit week 0 4 and 8 body weight and composition will be determined and questionnaires and 3-day food record will be collected
This will be a randomized controlled two arm intervention study The study will be conducted in 30 healthy free-living subjects 21-55 years After 4-weeks of consuming a beige diet ie low-fiber low polyphenol diet 20 subjects will consume one bottle two servings of kombucha daily for 4 weeks and 10 subjects will not change their dietary habits At baseline week 0 week 4 and 8 blood will be collected On the day prior to the study visits at week 4 and 8 participants will collect a stool and bring it to the lab On the day of study visit week 0 4 and 8 body weight and composition will be determined and questionnaires and 3-day food record will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None