The Impact of Dietary Protein on the Metabolome

NCT05377892 | Completed

• 1 other identifier: IRB2019-00415
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

It is known that tumors have an affinity for taking up amino acids from circulation or nearby tissues to use as a fuel source, to enhance their growth. Work in rodents has shown that when the levels of amino acids are reduced in diet, tumor growth is slowed and tumors are more susceptible to anti-cancer therapies. There are limited evidence-based dietary recommendations for cancer patients, which represents an urgent and unmet need. It is likely that reducing dietary protein will be beneficial, however this has not been tested. In advance of carrying out a study in cancer patients a study in healthy volunteers needs to be conducted to determine whether altering the amount of dietary protein, impacts the levels of amino acids (or other metabolites) in blood or the intestine. By demonstrating that altering dietary protein can alter the metabolome of healthy individuals, it will provide the information needed to reduce protein intake in cancer patients in future studies.

Conditions

Diet, Healthy

Outcome Measures

Primary Outcomes (3)

• Subject reported adherence to study diet.

  Participants will take a picture of each meal before and after eating and upload the pictures via a Qualtrics-based survey. The investigators will use these images to estimate how much food has been eaten at each meal, then calculate macronutrient intake based on the nutrient content of each food item. Participants will log any consumption of food or beverages not provided for the study via this same Qualtrics-based survey in order to estimate the contribution of non-study foods to overall macronutrient consumption. The average percent change in protein intake across subjects after switching from acclimation to high protein or high protein to reduced protein stages will be quantified.

  5 weeks

• Mass spectrometry-based measurement of abundance of metabolites in blood

  Global metabolite profiling will be carried out using mass spectrometry on blood collected at the end of the acclimation, high protein and reduced protein stages. Data will be log transformed and paired t tests will be conducted to determine if significant changes in abundance occur following consumption of high protein or reduced protein diets

  4 weeks

• Mass spectrometry-based measurement of abundance of metabolites in stool

  Global metabolite profiling will be carried out using mass spectrometry on stool collected at the end of the acclimation, high protein and reduced protein stages. Data will be log transformed and paired t tests will be conducted to determine if significant changes in abundance occur following consumption of high protein or reduced protein diets

  4 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Subjects receiving high protein followed by reduced protein diet

Other: Dietary protein

Interventions

Dietary protein OTHER

High protein followed by reduced protein diet

Intervention

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-30 years
• BMI 18-29.9

You may not qualify if:

• 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 vegetarian or vegan diet.
• Those having taken antibiotics within 1 month of starting the study

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Interventions

Dietary Proteins

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David Montrose, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: single blinded (participant)
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pathology

Model Details: Longitudinal

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 17, 2022
• Study Start: November 4, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2022; indefinitely
• Access Criteria: subscription access to journal

Locations

US (1)