Impact of Protein Source on Gut Health

Study Overview
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Brief Summary
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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.

Official Title
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Determining the Effect of Dietary Protein Source on Intestinal Health

Conditions
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Diet, Healthy

Intervention / Treatment
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* Dietary Supplement: Protein isolate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI of 18-29.9 Exclusion Criteria: Those with a history of significant illness including diabetes, renal, liver or cardiovascular disease, malnutrition, GI disease (including IBS, IBD, chronic constipation or diarrhea), mental illness (i.e. depression, bipolar disorder) Those adhering to a vegan diet or vegetarian diet exclusive of eggs Those having taken probiotics or antibiotics within 1 month of starting the study Those who are pregnant or plan to become pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pea protein to egg white protein<br>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. | Dietary Supplement: Protein isolate<br>* The indicated protein isolates will be given to subjects as their major protein source<br>|
| Experimental: Egg white protein to pea protein<br>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. | Dietary Supplement: Protein isolate<br>* The indicated protein isolates will be given to subjects as their major protein source<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Daily over two, 10-day periods |