Dietary Protein and Monocyte/Macrophage Mammalian Target of Rapamycin (mTOR) Signaling

NCT03946774 | Terminated

• 1 other identifier: 201808084
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

High protein low carbohydrate diets have become popular in recent years to help facilitate weight loss. It is controversial if these diets are associated with an increased risk of cardiovascular disease. The investigators propose to administer high and low protein shakes to participants and measure effects on circulating monocytes, immune cells critical to the development of atherosclerosis and cardiovascular disease. In order to study circulating monocytes, blood will be collected from the study participants just prior to drinking the shake, and then 1 and 4 hours after drinking the shake. In order to assess functional effects on monocytes, investigators will perform a series of assays comparing the results between individuals who drank high protein vs low protein shakes.

Conditions

Dietary Protein

Keywords

Atherosclerosis; Macrophage/monocyte; mTOR; Autophagy; Apoptosis; Inflammation

Outcome Measures

Primary Outcomes (1)

• Determination of amino acid levels and mTOR activation in circulating monocytes isolated from subjects ingesting high vs low protein drinks.

  Changes in amino acid levels and corresponding changes in mTOR activation will be quantified at baseline (time 0 hour prior to ingestion of a protein shake), then at 1 and 3 hours after ingestion of a protein shake.

  0 Hour, 1 Hour, and 3 Hours

Secondary Outcomes (3)

• Determination of changes in autophagy and apoptosis markers in circulating monocytes over time after ingestion of a protein shake

  0 Hour, 1 Hour and 3 Hours

• Determination of changes in reactive oxygen species in circulating monocytes over time after ingestion of a protein shake.

  0 Hour, 1 Hour, and 3 Hours

• Determination of changes in inflammatory markers in circulating monocytes over time after ingestion of a protein shake.

  0 Hour, 1 Hour, and 3 Hours

Study Arms (2)

High protein

ACTIVE COMPARATOR

Subjects getting high protein shake

Dietary Supplement: Dietary protein shake

Low protein

ACTIVE COMPARATOR

Subjects getting low protein shake

Dietary Supplement: Dietary protein shake

Interventions

Dietary protein shake DIETARY_SUPPLEMENT

It is a milk based protein shake. Ingredients include a combination of the following depending on protein content: Boost Plus (a commercial supplement), Unjury (a commercial whey protein isolate), nonfat dry milk powder, Sol Carb (commercial supplement composed of a carbohydrate polymer), canola oil, and water. In order to ensure consistency across all participants each beverage will be prepared in the Clinical Translational Research Unit Metabolic Kitchen under the supervision of a registered dietitian prior to the study participant's visit. Ingredients are individually weighed on a food scale by metabolic kitchen staff to the nearest 0.1 g and then mixed using a magnetic stir plate. Nutritional breakdown of the smoothies (high versus low protein): High protein drink nutrition: 500 kcal per serving, 50% protein, 17% fat, and 36% carbohydrate. Low (standard) protein drink nutrition: 500 kcal per serving, 10% protein, 17% fat, and 73% carbohydrate.

High protein; Low protein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age
• Able to drink milk based protein shake

You may not qualify if:

• Current Pregnancy
• Any food allergies
• Personal Hx of Diabetes
• Personal Hx of Heart Disease
• Personal Hx of High blood pressure
• Personal Hx of Stroke
• Personal Hx of Cancer
• Personal Hx of Organ transplant
• Taking Rapamycin/Sirolimus
• Taking Torisel/Temsirolimus
• Taking Afinitor/Everolimus
• Taking any statin medication (eg.simvastatin/atorvastatin/rosuvastatin etc)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Inflammation

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: May 13, 2019
• Study Start: October 1, 2019
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)