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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks after the intervention

Awards & highlights

HP Trial 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.Check my eligibility

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.See study design

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.

HP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 21 and 70 years old.

HP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks after the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks after the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks after the intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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

Endothelial function, assessed as reactive hyperemia index

Postprandial plasma amino acid concentration

Postprandial plasma glucose concentration

+2 more

HP 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

361 Previous Clinical Trials

627,894 Total Patients Enrolled

7 Trials studying Metabolic Syndrome

1,109 Patients Enrolled for Metabolic Syndrome

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,773 Total Patients Enrolled

12 Trials studying Metabolic Syndrome

2,006 Patients Enrolled for Metabolic Syndrome

Bettina MittendorferPrincipal InvestigatorUniversity of Missouri-Columbia

5 Previous Clinical Trials

184 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accommodate elderly persons aged over 85?

"This medical trial is open to those aged 21 or older, and below 70 years of age."

Answered by AI

Is this study open for enrolment at the present time?

"Affirmative. According to clinicaltrials.gov, the trial posted on July 12th 2019 is currently accepting participants and was recently updated on April 9th 2022. The medical study is looking for 100 individuals from a single site."

Answered by AI

Who is authorized to participate in this experiment?

"This medical trial is open to 100 participants aged 21-70 with glucose metabolism disorders. In addition, they must have a BMI of 24.5-32.5 kg/m2 and consume less than 0.9 g/kg protein daily (as confirmed by the HealthWatch 360 app)."

Answered by AI

What is the current extent of participant involvement in this experiment?

"Affirmative. The information uploaded to clinicaltrials.gov indicates that this research project, inaugurated on July 12th 2019, is presently gathering participants. There are 100 openings at 1 trial site currently available."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Animal and Plant Proteins and Glucose Metabolism

Bettina Mittendorfer 2019. "Animal and Plant Proteins and Glucose Metabolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03994367.

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