Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| USDA Beltsville Human Nutrition Research Center | FED |
Not provided
Not provided
Not provided
Not provided
The gastrointestinal (GI) tract is a central hub for human health given its essential role in nutrient absorption, waste production and immunity. Diet is a major contributor to gut health including affecting the incidence and severity of GI disease. This is mediated, at least in part, by the presence of microbiota, a highly diet-dependent biome. In fact, dietary changes are capable of altering bacterial populations and/or microbial metabolism, which in turn, controls the type and abundance of small molecules being produced in the gut, many of which can exert biological effects. Several lines of evidence suggest that dietary protein in particular, can impact gut health. Therefore, this trial will test whether dietary protein type differentially impacts gut function in humans by carrying out a single-blinded randomized cross-over controlled feeding study in healthy individuals. Subjects will be provided with an individualized very low protein diet augmented with pea- or egg white-derived protein supplements, as their major protein source. The impact of consuming pea vs. egg white protein on 1) the fecal metabolome, 2) gut barrier function and 3) gastrointestinal symptoms will be determined.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pea protein to egg white protein | Experimental | This arm will receive 10 days of pea protein isolate followed by 10 days of consuming egg white protein isolate, with the two treatment periods separated by a 14-day washout period. |
|
| Egg white protein to pea protein | Experimental | This arm will receive 10 days of egg white protein isolate followed by 10 days of consuming pea protein isolate, with the two treatment periods separated by a 14-day washout period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein isolate | Dietary Supplement | The indicated protein isolates will be given to subjects as their major protein source |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal metabolome | Mass-spectrometry based analysis of the relative abundance of metabolites will be carried out on feces. | This analysis will be carried out at baseline and the end of each treatment period, entailing 4 measurements over an approximately 36 day period |
| Intestinal permeability | Subjects will undergo lactulose-mannitol test to inform on gut permeability | This analysis will be carried out at baseline and the end of each treatment period, entailing 4 measurements over an approximately 36 day period |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to study diets | consumption of study diets will be recorded through subject-reported surveys before and after eating. | Daily over two, 10-day periods |
| Amount of study diets consumed | Subjects will take pictures of food items before and after eating to assess the amount of each study diet item consumed. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David C Montrose, PhD | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University | Stony Brook | New York | 11794 | United States |
Not provided
This study is designed as a single-blinded randomized crossover trial in which individuals will be assigned to 2 groups. One group will receive 10 days of pea protein isolate followed by 10 days of consuming egg white protein isolate, with the two treatment periods separated by a 14-day washout period. The second group will receive the isolates in the opposite order.
Not provided
Not provided
Subjects will be blinded as to which protein type they are receiving.
| Daily over two, 10-day periods |