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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-70
SponsorUniversity of Arkansas

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Whey Protein Isolate Crossover

    Dietary supplement

    This crossover intervention includes 1 week of whey protein isolate supplementation and 1 week of placebo supplementation.

  • Placebo

    Dietary supplement

    1 week of Non-whey protein Placebo supplement

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Whey Protein SupplementationExperimental treatment 1 intervention
Group B: Placebo SupplementationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
7 days
2

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.

Time frame
7 days
3

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.

Time frame
7 days

Secondary outcomes

1

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.

Time frame
7 days
2

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.

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arkansas

Lead sponsor

National Dairy Council

Collaborator