Metabolic SyndromeHPNCT03994367
Animal and Plant Proteins and Glucose Metabolism
A study testing High animal protein isolate, High animal protein whole food and High plant protein isolate in people with Metabolic Syndrome and Metabolic Syndrome, Protection Against, run by University of Missouri-Columbia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Metabolic Syndrome, Protection Against, Glucose Metabolism Disorders
- What is being tested?
- High animal protein isolate, High animal protein whole food and High plant protein isolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2019to 25 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri School of Medicine
Columbia, Missouri, 65212
BETTINA MITTENDORFER, 618-610-3465, b.mittendorfer@missouri.edu
b.mittendorfer@missouri.edu
About this study
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.
- Being tested
- High animal protein isolate, High animal protein whole food, High plant protein isolate, High plant protein whole food
- Keywords
- High Protein, Metabolism, Diet
- Medical subject headings
- Metabolic Syndrome, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High animal protein isolateOther
Increased dietary protein content from animal protein isolates
High animal protein whole foodOther
Increased dietary protein content from animal protein whole food
High plant protein isolateOther
Increased dietary protein content from plant protein isolates
High plant protein whole foodOther
Increased dietary protein content from animal protein whole food
| Study group | Role | What they receive |
|---|---|---|
| Standard protein (control) | No intervention | Not described |
| High animal protein isolate | Experimental | Not described Receives: Other: High animal protein isolate |
| High animal protein whole food | Experimental | Not described Receives: Other: High animal protein whole food |
| High plant protein isolate | Experimental | Not described Receives: Other: High plant protein isolate |
| High plant protein whole food | Experimental | Not described Receives: Other: High plant protein whole food |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour plasma glucose concentration
Measured: up to 12 weeks after the intervention
Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure
Measured: up to 12 weeks after the intervention
Secondary outcomes (5)
Postprandial plasma glucose concentration
Measured: up to 12 weeks after the intervention
mTOR signaling (phospho-S6 content) in circulating monocytes
Measured: up to 12 weeks after the intervention
Endothelial function, assessed as reactive hyperemia index
Measured: up to 12 weeks after the intervention
Postprandial plasma insulin concentration
Measured: up to 12 weeks after the intervention
Postprandial plasma amino acid concentration
Measured: up to 12 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start12 Jul 2019
- Primary completion25 Feb 2028 (estimated)
- Study completion25 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bettina Mittendorfer, University of Missouri-Columbia
- Investigators
- Bettina Mittendorfer, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994367
- Sponsor's protocol ID
- 2097498
- Acronym
- HP
- Status last verified
- Apr 2026
- First submitted
- 18 Jun 2019
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fappi A, Shabrish V, Hollomon H, Islam T, Zhang X, Razani B, Klein S, Mittendorfer B. High animal protein and high plant protein meals differentially alter postprandial plasma amino acid concentrations but not glucose homeostasis in people with overweight/obesity in a randomized, cross-over, single-meal study. Am J Clin Nutr. 2026 Aug 10:101468. doi: 10.1016/j.ajcnut.2026.101468. Online ahead of print.
PubMed 42575285
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animal and Plant Proteins and Glucose Metabolism
- ClinicalTrials.gov ID
- NCT03994367
- Acronym / sponsor ID
- HP / 2097498
- Keywords
- High Protein, Metabolism, Diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 25 Feb 2028 (estimated)
- Study completion
- 25 Apr 2028 (estimated)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Standard protein (control) | No intervention | – |
| High animal protein isolate | Experimental | Other: High animal protein isolate |
| High animal protein whole food | Experimental | Other: High animal protein whole food |
| High plant protein isolate | Experimental | Other: High plant protein isolate |
| High plant protein whole food | Experimental | Other: High plant protein whole food |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High animal protein isolateIncreased dietary protein content from animal protein isolates | Other | High animal protein isolate |
| High animal protein whole foodIncreased dietary protein content from animal protein whole food | Other | High animal protein whole food |
| High plant protein isolateIncreased dietary protein content from plant protein isolates | Other | High plant protein isolate |
| High plant protein whole foodIncreased dietary protein content from animal protein whole food | Other | High plant protein whole food |
Primary outcome
24-hour plasma glucose concentration
Time frame: up to 12 weeks after the intervention
Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure
Time frame: up to 12 weeks after the intervention
5 secondary outcomes
Postprandial plasma glucose concentration
Time frame: up to 12 weeks after the intervention
mTOR signaling (phospho-S6 content) in circulating monocytes
Time frame: up to 12 weeks after the intervention
Endothelial function, assessed as reactive hyperemia index
Time frame: up to 12 weeks after the intervention
Postprandial plasma insulin concentration
Time frame: up to 12 weeks after the intervention
Postprandial plasma amino acid concentration
Time frame: up to 12 weeks after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 42575285Fappi A, Shabrish V, Hollomon H, Islam T, Zhang X, Razani B, Klein S, Mittendorfer B. High animal protein and high plant protein meals differentially alter postprandial plasma amino acid concentrations but not glucose homeostasis in people with overweight/obesity in a randomized, cross-over, single-meal study. Am J Clin Nutr. 2026 Aug 10:101468. doi: 10.1016/j.ajcnut.2026.101468. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bettina Mittendorfer principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High animal protein isolate, High animal protein whole food and High plant protein isolate in people with Metabolic Syndrome and Metabolic Syndrome, Protection Against, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BETTINA MITTENDORFER (618-610-3465, b.mittendorfer@missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour plasma glucose concentration (time frame: up to 12 weeks after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03994367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.