Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet (Microbiota)
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|ClinicalTrials.gov Identifier: NCT03266536|
Recruitment Status : Active, not recruiting
First Posted : August 30, 2017
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Small Intestine Bacteria||Behavioral: Western diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet|
|Study Start Date :||January 2017|
|Actual Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2020|
No Intervention: No western diet
Participants will undergo one-time testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will be finished with testing after the upper endoscopy is complete.
Experimental: Western diet
Participants will undergo a first day of testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will then consume a Western diet for 7 days before a second day of identical testing (blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies).
Behavioral: Western diet
Western diet for 7 days: the meals in this Western diet will be provided by the Clinical Research and Trials Unit (CRTU) after participants meet with the nutrition staff (to discuss food preferences, how to obtain the meals). The meals will reflect a typical Western diet: a low fiber, high sugar diet with weight maintenance calories with < 10 grams fiber per day, and a typical US macronutrient calorie distribution of 50% carbs, 35% fat and 15% protein, with no alcohol. At least 50% of carbohydrates will be provided as simple sugars.
- Transcriptional changes in gut microbiota present in stool. [ Time Frame: Baseline, approximately three weeks. ]DNA extraction from stool samples will be done using standard assays.
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): NCT03266536
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Purna C Kashyap, M.B.B.S.||Mayo Clinic|