About this trial
To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Crossover
Treatments tested in this trial
Whey Protein Isolate Crossover
Dietary supplementThis crossover intervention includes 1 week of whey protein isolate supplementation and 1 week of placebo supplementation.
Placebo
Dietary supplement1 week of Non-whey protein Placebo supplement
Treatment groups
Trial outcomes
Primary outcomes
Whole body protein turnover
Whole body protein turnover reflects the continual synthesis and breakdown of body proteins. It can be measured at a whole-body or tissue level using stable isotope methods.
Oral Glucose Tolerance Test
Oral Glucose Tolerance Test (OGTT) is used to screen for or diagnose diabetes. Normal blood values for a 75 gram OGTT are: Fasting -- 60 to 99 mg/dL (3.3 to 5.5 mmol/L), 1 hour -- Less than 200 mg/dL (11.1 mmol/L), 2 hours -- Less than 140 mg/dL (7.8 mmol/L) is normal.
Blood glucose
Continuous glucose monitoring means using a device to automatically estimate your blood glucose level, also called blood sugar, throughout the day and night for 7 days.
Secondary outcomes
Composite Appetite Scale
A composite appetite scale is a measure used to assess appetite control and influence energy intake. It can be calculated based on factors such as hunger, desire to eat, and fullness rating. Appetite Scale: How Hungry do you feel? Not Hungry at all \<---\> Have never been more Hungry How Satisfied do you feel? Completely empty \<----\> Can't eat another bite How Full do you feel? Not full at all \<----\> Totally full The more a person is satisfied and feels full and less hungry, the better the outcome is for whey vs placebo supplementation.
Dietary Intake Log
A dietary intake log, also known as a food diary, is a self-reported account of all foods and beverages consumed within a specific timeframe.
Sponsors and contacts
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University of Arkansas
Lead sponsor
National Dairy Council
Collaborator