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Animal vs. Plant Proteins for Diabetes (HP Trial)

N/A
Recruiting
Led By Bettina Mittendorfer
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
age: ≥21 and ≤70 years;
Be older than 18 years old
Must not have
prediabetes or type 2 diabetes;
evidence of significant organ system dysfunction or diseases (e.g., cirrhosis), and
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at different types of protein to see how they affect insulin levels and metabolism.

Who is the study for?
This trial is for adults aged 21-70 with a BMI between 24.5 and 32.5, who consume low protein diets and exercise minimally. Participants should be weight stable without significant organ dysfunction, chronic kidney disease, or metabolic conditions like diabetes. They must not have allergies to the study foods, take certain supplements or medications affecting the outcomes, be vegetarians/vegans, use tobacco excessively or drink alcohol.
What is being tested?
The study examines how high-protein diets from different sources (animal vs plant-based; whole foods vs isolates) affect insulin sensitivity in liver and muscle, response to meals, and daily levels of glucose and hormones related to metabolism. It aims to understand if these proteins can influence metabolic health differently.
What are the potential side effects?
While specific side effects are not listed for this dietary intervention trial, changes in diet could potentially cause digestive discomforts such as bloating or gas especially when increasing protein intake significantly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have prediabetes or type 2 diabetes.
Select...
I do not have major organ system diseases like cirrhosis.
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I have chronic kidney disease, confirmed by tests.
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I haven't taken antibiotics or antifungals in the last 2 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: High plant protein whole foodExperimental Treatment1 Intervention
Group II: High plant protein isolateExperimental Treatment1 Intervention
Group III: High animal protein whole foodExperimental Treatment1 Intervention
Group IV: High animal protein isolateExperimental Treatment1 Intervention
Group V: Standard protein (control)Active Control1 Intervention

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
379 Previous Clinical Trials
628,394 Total Patients Enrolled
7 Trials studying Metabolic Syndrome
1,109 Patients Enrolled for Metabolic Syndrome
Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,765 Total Patients Enrolled
12 Trials studying Metabolic Syndrome
1,933 Patients Enrolled for Metabolic Syndrome
Bettina MittendorferPrincipal InvestigatorUniversity of Missouri-Columbia
6 Previous Clinical Trials
244 Total Patients Enrolled

Media Library

High animal protein whole food Clinical Trial Eligibility Overview. Trial Name: NCT03994367 — N/A
Metabolic Syndrome Research Study Groups: High animal protein isolate, Standard protein (control), High animal protein whole food, High plant protein isolate, High plant protein whole food
Metabolic Syndrome Clinical Trial 2023: High animal protein whole food Highlights & Side Effects. Trial Name: NCT03994367 — N/A
High animal protein whole food 2023 Treatment Timeline for Medical Study. Trial Name: NCT03994367 — N/A
~4 spots leftby Feb 2025
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