Back to resultsAnimal and Plant Proteins and Glucose Metabolism (HP)
Primary Purpose
Metabolic Syndrome, Metabolic Syndrome, Protection Against, Glucose Metabolism Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High animal protein isolate
High animal protein whole food
High plant protein isolate
High plant protein whole food
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring High Protein, Metabolism, Diet
Eligibility Criteria
Inclusion Criteria:
- age: ≥21 and ≤70 years;
- BMI: >24.5 and <32.5 kg/m2;
- habitual protein intake <0.9 g/kg/day (assessed on 2 weekdays and 2 weekend days by using the HealthWatch 360 app); and
- weight stable (i.e., ≤3% change) and untrained (≤150 min of structured exercise/week) for at least 2 months before entering the study.
Exclusion Criteria:
- prediabetes or type 2 diabetes;
- evidence of chronic kidney disease by medical history or laboratory tests (glomerular filtration rate <60 ml/min/1.73 m2 or an albumin to creatinine ratio in urine ≥30 mg/g);
- vegetarians or vegans;
- intolerance or allergies to ingredients in the metabolic meal or intervention diet;
- take dietary supplements (e.g., pre- and probiotics, fiber, fish oil) or medications known to affect our study outcomes;
- received antibiotic or antifungal treatment (which affect the microbiome and therefore microbial metabolite production) 2 months before entering the study;
- consume tobacco products or excessive alcohol (women: >14 drinks/week; men: >21 drinks/week);
- evidence of significant organ system dysfunction or diseases (e.g., cirrhosis), and
- unwilling or unable to provide informed consent.
Sites / Locations
- Washington University in St. LouisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
No Intervention
Experimental
Experimental
Experimental
Experimental
Arm Label
Standard protein (control)
High animal protein isolate
High animal protein whole food
High plant protein isolate
High plant protein whole food
Arm Description
Outcomes
Primary Outcome Measures
24-hour plasma glucose concentration
Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure
Secondary Outcome Measures
Postprandial plasma glucose concentration
mTOR signaling (phospho-S6 content) in circulating monocytes
Endothelial function, assessed as reactive hyperemia index
Postprandial plasma insulin concentration
Postprandial plasma amino acid concentration
Full Information
NCT ID
NCT03994367
First Posted
June 18, 2019
Last Updated
June 16, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03994367
Brief Title
Animal and Plant Proteins and Glucose Metabolism
Acronym
HP
Official Title
Animal and Plant Proteins and Glucose Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2019 (Actual)
Primary Completion Date
February 25, 2025 (Anticipated)
Study Completion Date
April 25, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this proposal is to determine the effect of a high protein diet in which the increase in protein intake is derived from different sources (animal vs plant and protein-rich whole foods vs protein isolates) on: i) liver and muscle insulin sensitivity; ii) the metabolic response to a meal, and iii) 24-h plasma concentration profiles of glucose, glucoregulatory hormones, and protein-derived metabolites purported to cause metabolic dysfunction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Metabolic Syndrome, Protection Against, Glucose Metabolism Disorders
Keywords
High Protein, Metabolism, Diet
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard protein (control)
Arm Type
No Intervention
Arm Title
High animal protein isolate
Arm Type
Experimental
Arm Title
High animal protein whole food
Arm Type
Experimental
Arm Title
High plant protein isolate
Arm Type
Experimental
Arm Title
High plant protein whole food
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
High animal protein isolate
Intervention Description
Increased dietary protein content from animal protein isolates
Intervention Type
Other
Intervention Name(s)
High animal protein whole food
Intervention Description
Increased dietary protein content from animal protein whole food
Intervention Type
Other
Intervention Name(s)
High plant protein isolate
Intervention Description
Increased dietary protein content from plant protein isolates
Intervention Type
Other
Intervention Name(s)
High plant protein whole food
Intervention Description
Increased dietary protein content from animal protein whole food
Primary Outcome Measure Information:
Title
24-hour plasma glucose concentration
Time Frame
up to 12 weeks after the intervention
Title
Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure
Time Frame
up to 12 weeks after the intervention
Secondary Outcome Measure Information:
Title
Postprandial plasma glucose concentration
Time Frame
up to 12 weeks after the intervention
Title
mTOR signaling (phospho-S6 content) in circulating monocytes
Time Frame
up to 12 weeks after the intervention
Title
Endothelial function, assessed as reactive hyperemia index
Time Frame
up to 12 weeks after the intervention
Title
Postprandial plasma insulin concentration
Time Frame
up to 12 weeks after the intervention
Title
Postprandial plasma amino acid concentration
Time Frame
up to 12 weeks after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age: ≥21 and ≤70 years;
BMI: >24.5 and <32.5 kg/m2;
habitual protein intake <0.9 g/kg/day (assessed on 2 weekdays and 2 weekend days by using the HealthWatch 360 app); and
weight stable (i.e., ≤3% change) and untrained (≤150 min of structured exercise/week) for at least 2 months before entering the study.
Exclusion Criteria:
prediabetes or type 2 diabetes;
evidence of chronic kidney disease by medical history or laboratory tests (glomerular filtration rate <60 ml/min/1.73 m2 or an albumin to creatinine ratio in urine ≥30 mg/g);
vegetarians or vegans;
intolerance or allergies to ingredients in the metabolic meal or intervention diet;
take dietary supplements (e.g., pre- and probiotics, fiber, fish oil) or medications known to affect our study outcomes;
received antibiotic or antifungal treatment (which affect the microbiome and therefore microbial metabolite production) 2 months before entering the study;
consume tobacco products or excessive alcohol (women: >14 drinks/week; men: >21 drinks/week);
evidence of significant organ system dysfunction or diseases (e.g., cirrhosis), and
unwilling or unable to provide informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BETTINA MITTENDORFER
Phone
3148450
Email
mittendb@wustl.edu
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BETTINA MITTENDORFER
Phone
314-362-8450
Email
mittendb@wustl.edu
Ext
MITTENDORFER
Email
mittendb@wustl.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Animal and Plant Proteins and Glucose Metabolism
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