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

Trial Summary

What is the purpose of this trial?

To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals

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.

What data supports the effectiveness of the treatment Whey Protein Isolate for diabetes?

Research shows that whey protein can help manage blood sugar levels after meals in people with type 2 diabetes by increasing insulin release and slowing down digestion. This suggests that whey protein isolate might be beneficial for controlling blood sugar in diabetes. ^{1 2 3 4 5}

Is whey protein safe for humans?

Whey protein supplementation appears to be generally safe for humans, as studies have shown no substantial adverse effects in people with type 2 diabetes. However, more research is needed to confirm the optimal dose and long-term safety. ^{1 2 3 6 7}

How does whey protein isolate differ from other treatments for diabetes?

Whey protein isolate is unique because it can increase insulin secretion and improve blood sugar control after meals by delaying stomach emptying and enhancing the effects of certain hormones that help regulate blood sugar. This makes it different from other diabetes treatments that primarily focus on directly lowering blood sugar levels. ^{1 2 3 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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 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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Change of some oxidative stress parameters after supplementation with whey protein isolate in patients with type 2 diabetes. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Biochemical and metabolic mechanisms by which dietary whey protein may combat obesity and Type 2 diabetes. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Whey protein: The "whey" forward for treatment of type 2 diabetes? [2022]

6. United States 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. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of whey protein supplementation on adiposity, body weight, and glycemic parameters: A synthesis of evidence. [2023]

8. England 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Metabolic effects of amino acid mixtures and whey protein in healthy subjects: studies using glucose-equivalent drinks. [2023]