Whey Protein for Diabetes

(DAIRY Trial)

Overseen By Arny Ferrando, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Must not be taking: Insulin, GLP/GIP, Corticosteroids, others

Disqualifiers: Lactose intolerance, Cancer, Surgery, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how taking whey protein isolate, a type of protein supplement, twice daily affects blood sugar and insulin levels in individuals with prediabetes or diabetes. Researchers seek to discover if whey protein isolate can aid in managing these conditions. Participants will receive either whey protein isolate or a placebo, with the study alternating between these two groups. Suitable candidates have blood sugar levels indicating prediabetes or mild diabetes and can abstain from alcohol and marijuana during the study. As an unphased trial, this study provides a unique opportunity to contribute to research that could lead to new methods for managing blood sugar levels.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using insulin injections, certain appetite suppressants, androgen or anabolic therapy, or corticosteroids. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that whey protein isolate is likely to be safe for humans?

Research has shown that whey protein is generally safe for people. It can help manage blood sugar and insulin levels, benefiting those with diabetes. Found in many foods and supplements, most people consume whey protein without issues.

Studies often focus on whey protein's ability to lower blood sugar after meals, helping to stabilize blood sugar levels. The reviewed studies reported no major safety concerns. Most people tolerate whey protein well, experiencing very few side effects.

In summary, current research indicates that whey protein is a safe choice. It is widely used and has a good track record for helping control blood sugar. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about whey protein isolate for diabetes because it offers a natural, nutrition-based approach, unlike conventional medications that often focus on insulin regulation or blood sugar reduction. Whey protein might help manage blood sugar levels by slowing digestion and improving insulin response, presenting a potentially simpler and more holistic option. Additionally, whey protein is easily accessible and could be a cost-effective supplement to existing therapies, making it an attractive choice for individuals seeking complementary ways to manage their diabetes.

What evidence suggests that whey protein might be an effective treatment for diabetes?

Research has shown that whey protein can help control blood sugar in people with diabetes. One study found that taking whey protein before meals reduced blood sugar spikes by about 1.4 mmol/L. Another study discovered that whey protein slows the rate at which the stomach empties, aiding in better insulin management. Regular whey protein consumption may also improve overall blood sugar control, blood pressure, and triglyceride levels, a type of fat in the blood. In this trial, participants will receive either whey protein supplementation or a placebo in a crossover study to evaluate its effectiveness. These findings suggest that whey protein could be a useful addition for those looking to manage their blood sugar levels effectively. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for men and women aged 50-70 who are pre-diabetic or diabetic (HbA1c: 5.7-6.4% or 6.5% to 7.5%), can consent, COVID-19 negative/asymptomatic, don't consume alcohol/marijuana/CBD during the study, and will keep a food journal. Excludes those with chronic inflammatory diseases, lactose intolerance, low hemoglobin levels, pregnant/nursing individuals, unwilling to fast overnight or wear a CGM device.

Inclusion Criteria

I am able to understand and agree to the study's procedures and risks.

HbA1c: 5.7-6.4% or 6.5% to 7.5%

I do not have COVID-19 or any symptoms.

Exclusion Criteria

I have a chronic inflammatory disease like Lupus or Crohn's.

Unwilling to keep a detailed 7 day food journal on two occasions

I am taking insulin or other medications to manage my appetite or diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume whey protein twice daily, within 1 hour of waking and 30 minutes prior to dinner, to assess effects on glucose control and appetite over 7 days

1 week

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whey Protein Isolate

Trial Overview

The trial tests how twice-daily whey protein affects blood sugar and insulin in pre-diabetic and diabetic individuals over two separate week-long periods while monitoring their diet through journals and continuous glucose measurements.

How Is the Trial Designed?

Group I: Whey Protein Supplementation Experimental Treatment 1 Intervention

Crossover study

Group II: Placebo Supplementation Placebo Group 2 Interventions

Crossover study

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

National Dairy Council

Collaborator

Trials

20

Recruited

1,800+

Published Research Related to This Trial

In a study of 120 patients with type 2 diabetes, daily supplementation with undenatured whey protein isolate (WPI) for 3 months significantly reduced markers of oxidative stress and inflammation compared to a placebo group.

WPI supplementation also led to improvements in lipid profiles and reductions in fasting plasma glucose levels, suggesting it may be beneficial for managing diabetes and its complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change of some oxidative stress parameters after supplementation with whey protein isolate in patients with type 2 diabetes. Derosa, G., D'Angelo, A., Maffioli, P.[2022]

In a study of 58 children with Type 1 Diabetes (T1D), consuming a whey isolate protein drink without additional insulin resulted in lower postprandial glycemia (PPG) when a square-wave insulin bolus was administered compared to no bolus, indicating that insulin may not be necessary for pure-protein meals.

The study also found that using a square-wave bolus significantly reduced the frequency of hypoglycemia compared to not using a bolus, suggesting that careful insulin management can help maintain better blood sugar levels after protein-rich meals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pure-protein load for children with type 1 diabetes: is any additional insulin needed? A randomized controlled study. Dżygało, K., Indulska, K., Szypowska, A.[2023]

Whey protein can effectively improve post-meal blood sugar levels by slowing down gastric emptying and stimulating the release of incretin hormones, which help regulate glucose levels.

It also directly stimulates insulin secretion from beta cells and suppresses appetite, making it a promising nutritional strategy for managing type 2 diabetes, although more research is needed to determine the best dosage and timing for consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey protein: The "whey" forward for treatment of type 2 diabetes? Mignone, LE., Wu, T., Horowitz, M., et al.[2022]

Whey protein supplementation significantly lowers postprandial blood sugar levels in individuals with type 2 diabetes, with reductions observed at both 60 minutes (-2.67 mmol/L) and 120 minutes (-1.59 mmol/L) after meals, based on a meta-analysis of 5 randomized controlled trials involving 134 participants.

The study also found that whey protein increased insulin levels after meals, indicating its potential to improve glycemic control without substantial adverse effects, although more research is needed to confirm these findings and determine optimal dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey protein supplementation improves postprandial glycemia in persons with type 2 diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials. Chiang, SW., Liu, HW., Loh, EW., et al.[2022]

Whey protein hydrolysates (WPHs) demonstrated a dose-dependent ability to stimulate insulin secretion in pancreatic cells, indicating their potential as antidiabetic agents.

In an 8-week study with ob/ob mice, WPH improved glucose clearance and reduced excessive insulin levels, suggesting it could be beneficial for managing diabetes by enhancing the pancreas's ability to secrete insulin in response to glucose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A whey protein hydrolysate promotes insulinotropic activity in a clonal pancreatic β-cell line and enhances glycemic function in ob/ob mice. Gaudel, C., Nongonierma, AB., Maher, S., et al.[2023]

A drink containing branched-chain amino acids (leucine, isoleucine, and valine) produced significantly higher insulin responses compared to a glucose-only reference drink, indicating their potential to stimulate insulin secretion.

The amino acid mixture closely mimicked the glycemic and insulinemic responses of whey protein, achieving a 44% reduction in glucose levels and a 31% increase in insulin levels, although it did not significantly affect GIP secretion like whey did.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic effects of amino acid mixtures and whey protein in healthy subjects: studies using glucose-equivalent drinks. Nilsson, M., Holst, JJ., Björck, IM.[2023]

Whey protein, a component of milk, has been shown to help control food intake and improve glucose metabolism, making it beneficial for managing obesity and Type 2 diabetes.

The positive effects of whey protein are linked to bioactive peptides and amino acids that stimulate gut hormones, enhancing insulin secretion and potentially inhibiting the degradation of incretins, which are important for regulating blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemical and metabolic mechanisms by which dietary whey protein may combat obesity and Type 2 diabetes. Jakubowicz, D., Froy, O.[2022]

Whey protein supplementation may help improve satiety and post-meal blood sugar control in overweight individuals and those with type 2 diabetes, particularly during short-term calorie restriction.

However, the long-term effects of whey protein on body weight, fat mass, and glycemic parameters remain unclear, indicating that more research is needed to establish its efficacy in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of whey protein supplementation on adiposity, body weight, and glycemic parameters: A synthesis of evidence. Giglio, BM., Lobo, PCB., Pimentel, GD.[2023]

Whey protein significantly increases postprandial insulin levels compared to white wheat bread, with serum from whey meals showing a notable rise in insulin secretion from isolated mouse pancreatic islets by 87% at 15 minutes and 139% at 30 minutes after ingestion.

The insulin-stimulating effect of whey protein is enhanced by specific amino acids and the incretin hormone GIP, with the combination of certain amino acids leading to a 270% increase in insulin secretion, further boosted to 558% when GIP is present.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The insulinogenic effect of whey protein is partially mediated by a direct effect of amino acids and GIP on β-cells. Salehi, A., Gunnerud, U., Muhammed, SJ., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10709019/

Whey Protein Supplementation and Type 2 Diabetes Mellitus ...

Collectively, evidence suggests WP supplementation may improve multiple clinical indicators of glucose control, along with triglycerides and blood pressure, in ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002916524014849

Effect of medium-chain triglycerides and whey protein ...

Sequential consumption of MCT and WPI preloads did not affect diurnal or 24-h glycaemia but lowered PPG and 24-h glycaemic variability in individuals with T2D.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4620107/

Whey protein: The “whey” forward for treatment of type 2 ...

Whey protein, a by-product of cheese-manufacture, shows promise in the dietary management of diabetes. Whey can slow gastric emptying, stimulate insulin and ...

4.

ajcn.nutrition.org

ajcn.nutrition.org/article/S0002-9165(23)48905-8/fulltext

Whey Protein Premeal Lowers Postprandial Glucose ...

Whey protein premeals lowered peak glucose concentration by −1.4 mmol/L [−1.9 mmol/L; −0.9 mmol/L], and the area under the curve for glucose was −0.9 standard ...

5.

drc.bmj.com

drc.bmj.com/content/5/1/e000420

Glucose-lowering effect of whey protein depends upon ...

Objective Whey protein (WP) intake has been shown to reduce postprandial glycemia. Majority of WP research in type 2 diabetes (T2DM) ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0261561424004448

The effects of whey protein supplementation on indices ...

Accordingly, studies have reported whey protein ingestion to elicit improvements in postprandial glycemic and insulin control [14] which may be attributed to ...

7.

nature.com

nature.com/articles/s41598-020-72975-8

Whey protein isolate inhibits hepatic FGF21 production ...

Our results demonstrated that intake of whey protein isolate decreased plasma 5-HT levels in mice.