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Animal and Plant Proteins and Glucose Metabolism (HP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994367
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Metabolic Syndrome, Protection Against Glucose Metabolism Disorders Other: High animal protein isolate Other: High animal protein whole food Other: High plant protein isolate Other: High plant protein whole food Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Animal and Plant Proteins and Glucose Metabolism
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : August 31, 2024

Arm Intervention/treatment
No Intervention: Standard protein (control)
Experimental: High animal protein isolate Other: High animal protein isolate
Increased dietary protein content from animal protein isolates

Experimental: High animal protein whole food Other: High animal protein whole food
Increased dietary protein content from animal protein whole food

Experimental: High plant protein isolate Other: High plant protein isolate
Increased dietary protein content from plant protein isolates

Experimental: High plant protein whole food Other: High plant protein whole food
Increased dietary protein content from animal protein whole food




Primary Outcome Measures :
  1. 24-hour plasma glucose concentration [ Time Frame: up to 12 weeks after the intervention ]
  2. Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure [ Time Frame: up to 12 weeks after the intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age: ≥40 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 T2D;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994367


Contacts
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Contact: BETTINA MITTENDORFER 3148450 mittendb@wustl.edu

Locations
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United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: BETTINA MITTENDORFER    314-362-8450    mittendb@wustl.edu   
Contact       mittendb@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03994367    
Other Study ID Numbers: 201904100
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
High Protein
Metabolism
Diet
Additional relevant MeSH terms:
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Metabolic Syndrome
Metabolic Diseases
Glucose Metabolism Disorders
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism