RECRUITING

Animal and Plant Proteins and Glucose Metabolism

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Animal and Plant Proteins and Glucose Metabolism

Quick Facts

Study Start:2019-07-12
Study Completion:2025-04-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03994367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * age: ≥21 and ≤70 years;
  2. * BMI: \>24.5 and \<32.5 kg/m2;
  3. * habitual protein intake \<0.9 g/kg/day (assessed on 2 weekdays and 2 weekend days by using the HealthWatch 360 app); and
  4. * weight stable (i.e., ≤3% change) and untrained (≤150 min of structured exercise/week) for at least 2 months before entering the study.
  1. * prediabetes or type 2 diabetes;
  2. * 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);
  3. * vegetarians or vegans;
  4. * intolerance or allergies to ingredients in the metabolic meal or intervention diet;
  5. * take dietary supplements (e.g., pre- and probiotics, fiber, fish oil) or medications known to affect our study outcomes;
  6. * received antibiotic or antifungal treatment (which affect the microbiome and therefore microbial metabolite production) 2 months before entering the study;
  7. * consume tobacco products or excessive alcohol (women: \>14 drinks/week; men: \>21 drinks/week);
  8. * evidence of significant organ system dysfunction or diseases (e.g., cirrhosis), and
  9. * unwilling or unable to provide informed consent.

Contacts and Locations

Study Contact

BETTINA MITTENDORFER
CONTACT
618-610-3465
b.mittendorfer@missouri.edu

Principal Investigator

Bettina Mittendorfer
PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia

Study Locations (Sites)

University of Missouri School of Medicine
Columbia, Missouri, 65212
United States

Collaborators and Investigators

Sponsor: University of Missouri-Columbia

  • Bettina Mittendorfer, PRINCIPAL_INVESTIGATOR, University of Missouri-Columbia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-12
Study Completion Date2025-04-25

Study Record Updates

Study Start Date2019-07-12
Study Completion Date2025-04-25

Terms related to this study

Keywords Provided by Researchers

  • High Protein
  • Metabolism
  • Diet

Additional Relevant MeSH Terms

  • Metabolic Syndrome
  • Metabolic Syndrome, Protection Against
  • Glucose Metabolism Disorders