Diet, Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTProtein isolate
The indicated protein isolates will be given to subjects as their major protein source
Sponsors
USDA Beltsville Human Nutrition Research Center
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Subjects will be blinded as to which protein type they are receiving.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal metabolome | This analysis will be carried out at baseline and the end of each treatment period, entailing 4 measurements over an approximately 36 day period | Mass-spectrometry based analysis of the relative abundance of metabolites will be carried out on feces. |
| Intestinal 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 | Subjects will undergo lactulose-mannitol test to inform on gut permeability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to study diets | Daily over two, 10-day periods | consumption of study diets will be recorded through subject-reported surveys before and after eating. |
| Amount of study diets consumed | Daily over two, 10-day periods | Subjects will take pictures of food items before and after eating to assess the amount of each study diet item consumed. |
Countries
United States
Outcome results
None listed