Animal vs. Plant Proteins for Diabetes

(HP Trial)

Recruiting at 1 trial location

Overseen By BETTINA MITTENDORFER

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must not be taking: Dietary supplements

Disqualifiers: Prediabetes, Diabetes, Kidney disease, Vegetarians, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different protein sources, such as animal or plant proteins, affect blood sugar control and metabolism. Researchers aim to determine if high-protein diets from whole foods or protein isolates (processed protein forms) impact insulin sensitivity and food processing. Participants should be adults without diabetes, not vegetarians or vegans, and have a stable weight with a typically low protein intake. As an unphased study, this trial provides a unique opportunity to contribute to understanding dietary impacts on health.

Will I have to stop taking my current medications?

The trial requires that you do not take medications known to affect the study outcomes. If you are on such medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that consuming large amounts of animal protein can increase the risk of developing insulin resistance and type 2 diabetes. It may also raise the risk of heart disease and other health issues. However, these diets typically do not pose problems for healthy individuals.

Conversely, studies suggest that diets rich in plant proteins are often safer and can aid in controlling blood sugar levels. Individuals who consume more plant-based proteins tend to have a lower risk of developing type 2 diabetes. These proteins may even enhance the body's response to insulin.

In summary, while high animal protein diets may carry certain risks, plant proteins are generally considered a safer choice for managing diabetes and promoting overall health. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore the impact of different protein sources on diabetes management, which is a fresh angle compared to traditional approaches focusing on glucose control through medications. Unlike standard diabetes treatments like Metformin or insulin, these investigational treatments involve dietary modifications with high animal or plant protein, either as isolates or whole foods. This approach could lead to new dietary strategies that might help regulate blood sugar levels and improve overall health. The potential for using food as medicine offers a promising and natural alternative that could complement existing therapies.

What evidence suggests that this trial's treatments could be effective for diabetes?

Research has shown that plant proteins might be better for managing diabetes. Studies have found that replacing animal protein with plant protein can lower the risk of type 2 diabetes by 23%. Plant-based diets not only help reduce blood sugar levels but also assist with weight control and improve insulin use. In contrast, diets high in animal protein have been linked to a higher risk of type 2 diabetes. This trial will compare different high-protein diets, including high animal protein isolate, high animal protein whole food, high plant protein isolate, and high plant protein whole food, to assess their effects on diabetes management. While both types of high-protein diets can help control blood sugar, plant proteins seem to offer more overall benefits for managing diabetes. ^{1 3 5 6 7}

Who Is on the Research Team?

Bettina Mittendorfer

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am between 21 and 70 years old.

Exclusion Criteria

I have prediabetes or type 2 diabetes.

I do not have major organ system diseases like cirrhosis.

You drink more alcohol than recommended (more than 14 drinks per week for women or more than 21 drinks per week for men) or use tobacco products.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants follow a high protein diet with protein intake from different sources (animal vs plant and protein-rich whole foods vs protein isolates) to assess effects on insulin sensitivity and metabolic response.

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after dietary intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High animal protein isolate
• High animal protein whole food
• High plant protein isolate
• High plant protein whole food

Trial Overview

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.

How Is the Trial Designed?

Group I: High plant protein whole food Experimental Treatment 1 Intervention

Group II: High plant protein isolate Experimental Treatment 1 Intervention

Group III: High animal protein whole food Experimental Treatment 1 Intervention

Group IV: High animal protein isolate Experimental Treatment 1 Intervention

Group V: Standard protein (control) Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

A low-protein diet (0.8 g/kg) may help individuals with diabetes who are experiencing macroalbuminuria, which is a sign of kidney damage.

Preliminary evidence indicates that vegetable proteins could be safely used to supplement or replace animal proteins without harming kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein, diabetes, and nephropathy. Franz, MJ.[2017]

Vegetarian diets, rich in whole grains, legumes, nuts, and fibers, have been associated with improved glycemic control and may help in the treatment of type 2 diabetes, as they can lower blood sugar levels and reduce the risk of complications.

Substituting plant proteins for animal proteins in vegetarian diets may decrease kidney strain and reduce the risk of renal disease in individuals with type 2 diabetes, highlighting the potential long-term health benefits of such dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 2 diabetes and the vegetarian diet. Jenkins, DJ., Kendall, CW., Marchie, A., et al.[2018]

In a controlled crossover study of 8 diabetic patients with chronic portal-systemic encephalopathy, a vegetable protein diet supplemented with fiber significantly reduced fasting glucose levels compared to a meat protein diet, with 7 out of 8 patients showing improvements.

The vegetable protein diet also led to an increase in bowel movements, indicating potential benefits for digestive health, while parameters of encephalopathy remained stable across both diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effect of vegetable protein diet supplemented with psyllium plantago in patients with hepatic encephalopathy and diabetes mellitus. Uribe, M., Dibildox, M., Malpica, S., et al.[2019]

A vegetarian diet can adequately provide the necessary protein for humans if energy needs are met and a variety of foods, such as legumes, grains, and nuts, are consumed.

Eating plant proteins instead of animal proteins may lower the risk of chronic diseases like diabetes and heart disease, highlighting the health benefits of a vegetarian diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein and vegetarian diets. Marsh, KA., Munn, EA., Baines, SK.[2020]

In a study of 40 Danish vegans, only 60% met their daily protein recommendations over three days, indicating a significant number of participants may not be getting enough protein in their diet.

The most limiting essential amino acid was lysine, with only 50% of participants meeting its recommendations daily, suggesting that a limited variety of protein sources in a vegan diet can lead to inadequate amino acid intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein content and amino acid composition in the diet of Danish vegans: a cross-sectional study. Aaslyng, MD., Dam, AB., Petersen, IL., et al.[2023]

In a study of eight patients with Type 1 diabetes and high albumin excretion rates, switching to a predominantly vegetarian diet for 8 weeks significantly reduced albumin excretion, indicating potential benefits for kidney health.

The reduction in albumin excretion was achieved without significantly altering total protein intake, and there were no adverse effects on blood glucose control or blood pressure, suggesting that a vegetarian diet could be a safe and effective dietary intervention for diabetic nephropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predominantly vegetarian diet in patients with incipient and early clinical diabetic nephropathy: effects on albumin excretion rate and nutritional status. Jibani, MM., Bloodworth, LL., Foden, E., et al.[2022]

Diets high in animal protein are linked to a higher risk of developing diabetes, suggesting that the source of protein matters for metabolic health.

The study indicates that consuming more protein, regardless of whether it's from animal or total sources, at the expense of carbohydrates or fats may also elevate the risk of diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein should be added to dietary advice on diabetes. [2019]

In a study of nine normotensive type I diabetic patients, a vegetable protein diet (VPD) resulted in lower glomerular filtration rate (GFR) and renal plasma flow (RPF) compared to an animal protein diet (APD), indicating that the type of protein consumed can affect kidney function.

The VPD led to higher renal vascular resistance and lower fractional clearance of albumin, suggesting that the renal effects of plant-based proteins differ significantly from those of animal proteins, potentially due to variations in amino acid profiles and insulin-like growth factor I (IGF-I) levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal, metabolic, and hormonal responses to proteins of different origin in normotensive, nonproteinuric type I diabetic patients. Kontessis, PA., Bossinakou, I., Sarika, L., et al.[2019]

Replacing animal protein with plant protein in the diet can lead to modest improvements in glycemic control for individuals with diabetes, as shown by significant reductions in HbA1c, fasting glucose, and fasting insulin levels across 13 randomized controlled trials involving 280 participants.

The study suggests that a median replacement of about 35% of total protein with plant sources is effective, but highlights the need for larger and higher-quality trials to confirm these findings and address uncertainties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Replacing Animal Protein with Plant Protein on Glycemic Control in Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Viguiliouk, E., Stewart, SE., Jayalath, VH., et al.[2023]

In a study of 436 patients with coronary heart disease, those who increased their intake of plant-based proteins had a 36% lower risk of developing type 2 diabetes mellitus over a median follow-up of 60 months.

The study found that higher plant protein intake was associated with increased consumption of carbohydrates, fiber, and legumes, while being linked to a decrease in saturated fatty acids, suggesting a beneficial dietary shift for diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Quantity of Protein Intake Influence Incidence of Type 2 Diabetes Mellitus in Coronary Heart Disease Patients: From the CORDIOPREV Study. de la Cruz-Ares, S., Gutiérrez-Mariscal, FM., Alcalá-Díaz, JF., et al.[2021]

Replacing animal protein with plant protein may lower total cholesterol and low-density lipoprotein (LDL) cholesterol levels, based on meta-analyses of 13 randomized controlled trials.

Cohort studies suggest that this dietary substitution is associated with reduced cardiovascular disease (CVD) mortality and lower incidence of type 2 diabetes (T2D), although the evidence is considered limited-suggestive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Animal versus plant-based protein and risk of cardiovascular disease and type 2 diabetes: a systematic review of randomized controlled trials and prospective cohort studies. Lamberg-Allardt, C., Bärebring, L., Arnesen, EK., et al.[2023]

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The goal of this clinical trial is to learn how different protein types affect the body's metabolism and immune system in healthy adults.