Functional Research of Emulsifiers in Humans (FRESH)
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|ClinicalTrials.gov Identifier: NCT03440229|
Recruitment Status : Active, not recruiting
First Posted : February 21, 2018
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: Emulsifier-containing diet||Not Applicable|
This is a randomized double-blind, controlled feeding experiment examining the effect of CMC on the stool microbiota composition, gene expression, and microbiota localization with respect to the epithelium. In addition, the investigators will assess the impact of CMC exposure in the diet on markers of metabolic syndrome including response to oral glucose tolerance testing and other plasma metabolite measurements.
Sixteen healthy volunteers will be recruited for a 11-day in-patient study. All participants will receive 3 full days of freshly prepared emulsifier-free food to begin the study. This will be called the "washout period". Participants will then be randomized into an "emulsifier-free" arm and a "CMC" arm in a 1:1 ratio.
Both arms will continue the same diet except that the "CMC" arm's brownie and sorbet will have CMC added to achieve a level of 15 gm per person per day consumption. Serial collection of fecal, plasma, urine and mucosal biopsy samples will be performed to investigate the extent to which CMC consumption by humans impacts the gut microbiota and its interaction with the host parameters related to inflammation and metabolism. Participants will have daily urine and stool collections. Sigmoidoscopies and glucose tolerance testing will be completed on day 1and 11. Blood samples are collected on days 1-4, 8, 10, and 11.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||This is a randomized double-blind controlled feeding experiment.|
|Official Title:||Functional Research of Emulsifiers in Humans|
|Actual Study Start Date :||April 6, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
No Intervention: Emuslfier-free diet
This is western style diet prepared without any emulsifiers. Emulsifier free brownies and sorbet are provided daily.
Experimental: Emulsifier-containing diet
This is a western style diet prepared without any emulsifiers with the exception of the CMC that is included in brownies and sorbet that are provided daily.
Other: Emulsifier-containing diet
CMC is one of many synthetic dietary emulsifiers that are incorporated into a variety of processed foods. We have recently shown that, in mice, consumption of P80 and CMC, alters microbiota composition, have pro-inflammatory potential and promote microbiota encroachment into the colonic mucosa, low-grade inflammation, and metabolic syndrome. However, it is not known whether these compounds have similar effects in humans. We would like to study these effects in the human gut microbiota.
Other Name: Carboxymethylcellulose (CMC)
- Distance of nearest bacteria to the epithelium [ Time Frame: 11 days ]Measured distance from the epithelium to the nearest bacteria under high powered microscopy
- Change in weight [ Time Frame: 11 days ]Comparison of weight change during the study period
- Area under glucose concentration curve [ Time Frame: Day 11 ]Area under the glucose concentration curves during the oral glucose tolerance test
- Area under insulin concentration curve [ Time Frame: Day 11 ]Area under the insulin concentration curves during the oral glucose tolerance test
- Satiety [ Time Frame: Days 10,11,15, and 16 ]Satiety is measured on a 10cm VAS. The mean value will be compared between the groups.
- Fecal lipocalin-2 [ Time Frame: Day 11 ]Fecal lipocalin-2 by Elisa
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): NCT03440229
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Jim Lewis, MD, MSCE||University of Pennsylvania|