Whey Protein Ingestion and Glucose Control in Pre- and Post Diabetic Individuals
Recruiting · NCT06694155 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Arkansas
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboWhey Protein Isolate Crossover
What this trial is about
To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals
Who can take part
Age range
50 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Males and females ages 50-70 years.
- Body mass index between 25-45 kg/m2
- Capable of providing informed consent.
- COVID-19 negative and/or asymptomatic.
- Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 7-day study meal period on two occasions.
- HbA1c: 5.7-6.4% or 6.5% to 7.5% or fasting glucose ≥100 mg/dL
Exclusion criteria
- Subject who does not/will not eat dairy protein sources.
- Subjects taking exogenous insulin injections or GLP /GIP injections or other appetite suppressants.
- Unwilling to keep a detailed 7 day food journal on two occasions
- Unwilling to wear a CGM for 7 days on two occasions and share the data with the research team.
- Lactose intolerance.
- Hemoglobin \<10g/dL at screening.
- History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
- History of gastrointestinal bypass/reduction surgery.
- Pregnant or lactating individuals.
- History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)
- Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
- Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).
- Unwilling to avoid using protein or amino-acid supplements during participation.
- Unwilling to fast overnight.
- Any medical condition or medication that the PI or clinical study staff finds contradictory to this study.
Where it is running
1 location listed across 1 US state.
- University of Arkansas for Medical Sciences - Little Rock, Arkansas, United States