Clinical trial NCT05619939: Impact of Protein Source on Gut Health
Official title: Determining the Effect of Dietary Protein Source on Intestinal Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: USDA Beltsville Human Nutrition Research Center
First posted: 2022-11-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fecal metabolome
timeFrame: 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: Intestinal permeability
timeFrame: 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 outcomes:
measure: Adherence to study diets
timeFrame: Daily over two, 10-day periods
measure: Amount of study diets consumed
timeFrame: Daily over two, 10-day periods
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: David C Montrose, PhD
role: PRINCIPAL_INVESTIGATOR
References: