Impact of Protein Source on Gut Health

Diet, Healthy Clinical Trial

Official title:

Determining the Effect of Dietary Protein Source on Intestinal Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05619939
• Other study ID #: 2022-00427
• Status: Completed
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: April 28, 2023

Study information

• Verified date: April 2024
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy

Intervention

Dietary Supplement:
• Protein isolate
The indicated protein isolates will be given to subjects as their major protein source

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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