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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Arny Ferrando, PhD
• Email: aferrando@uams.edu
• Phone: 5015265711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.