Effects of whey protein on blood sugar control in prediabetic and diabetic individuals

Whey Protein Ingestion and Glucose Control in Pre- and Post Diabetic Individuals

This study is testing whether drinking whey protein twice a day can help people with prediabetes and type 2 diabetes better control their blood sugar and appetite.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 50 Years to 70 Years
• Sex: All
• Sponsor: University of Arkansas (Academic / other)
• Drugs / interventions: chemotherapy, radiation, prednisone
• Locations: 1 site (Little Rock, Arkansas)
• Trial ID: NCT06694155 on ClinicalTrials.gov

What this trial studies

This study examines how consuming whey protein twice daily affects blood glucose and insulin levels in individuals with prediabetes and type 2 diabetes. Participants will ingest whey protein within one hour of waking and thirty minutes before dinner over a seven-day period. The study aims to assess changes in appetite, caloric intake, and glucose levels, comparing results between prediabetic and diabetic individuals. The methodology includes a crossover design with a placebo control to ensure robust results.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 50-70 years with HbA1c levels between 5.7%-7.5%.

Not a fit: Patients who are lactose intolerant or those on insulin or appetite suppressant medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved blood sugar control and appetite management for individuals with prediabetes and type 2 diabetes.

How similar studies have performed: Previous studies have shown promising results with dietary protein interventions in managing blood glucose levels, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Males and females ages 50-70 years.
2. Body mass index between 25-45 kg/m2
3. Capable of providing informed consent.
4. COVID-19 negative and/or asymptomatic.
5. Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 7-day study meal period on two occasions.
6. HbA1c: 5.7-6.4% or 6.5% to 7.5% or fasting glucose ≥100 mg/dL

Exclusion Criteria:

1. Subject who does not/will not eat dairy protein sources.
2. Subjects taking exogenous insulin injections or GLP /GIP injections or other appetite suppressants.
3. Unwilling to keep a detailed 7 day food journal on two occasions
4. Unwilling to wear a CGM for 7 days on two occasions and share the data with the research team.
5. Lactose intolerance.
6. Hemoglobin \<10g/dL at screening.
7. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
8. History of gastrointestinal bypass/reduction surgery.
9. Pregnant or lactating individuals.
10. History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)
11. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
12. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).
13. Unwilling to avoid using protein or amino-acid supplements during participation.
14. Unwilling to fast overnight.
15. Any medical condition or medication that the PI or clinical study staff finds contradictory to this study.

Where this trial is running

Little Rock, Arkansas

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)

Study contacts

• Study coordinator: Arny Ferrando, PhD

Conditions Prediabetes / Type 2 Diabetes; Whey Protein; type II diabetes; Protein turnover; Dietary intake