Prediabetes / Type 2 DiabetesDAIRYNCT06694155
Whey Protein Ingestion and Glucose Control in Pre- and Post Diabetic Individuals
A study testing Whey Protein Isolate Crossover in people with Prediabetes / Type 2 Diabetes, run by University of Arkansas at 1 site in United States.
Trial summary
To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Prediabetes / Type 2 Diabetes
- What is being tested?
- Whey Protein Isolate Crossover
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202
Samantha Seale, MS, 501-320-7602, sseale@uams.edu
About this study
To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals
Read the detailed description
Protein consumption in the morning has been shown to reduce appetite and caloric intake (19). In addition, premeal whey consumption reduces post prandial blood glucose, reduces gastric emptying rate, and increases peak blood insulin (10). Thus, it is proposed that ingestion of whey protein within 1hr of waking (and prior to breakfast) and 30 minutes prior to dinner will be more effective in suppressing appetite, carbohydrate intake, and glucose AUC. Ingestion upon waking will mitigate the cortisol-induced drive for carbohydrate intake. Ingestion prior to dinner, the most frequently consumed and largest meal in America (20), will reduce food intake, post meal blood glucose, and insulin area under the curve (21).
Specific Aims
- Determine the effect of WP ingestion within 1hr of waking and prior to breakfast, and 30min prior to dinner, on appetite suppression, carbohydrate and caloric intake, and 24hr glucose AUC over 7d in pre-diabetic (A1C 5.7%-6.4%) and diabetic (A1C 6.5%-7.5%) individuals.
- Determine the effect of WP ingestion within 1hr of waking and 30min prior to dinner on changes in OGTT, Matsuda index, and whole-body protein balance (compared to control) before and after 7d of WP consumption in pre-diabetic and diabetic individuals.
- Determine outcome differences between pre-diabetic and diabetic individuals.
- Conditions
- Prediabetes / Type 2 Diabetes
- Being tested
- Whey Protein Isolate Crossover, Placebo
- Keywords
- Whey Protein, type II diabetes, Protein turnover, Dietary intake
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein Isolate CrossoverDietary supplement
This crossover intervention includes 1 week of whey protein isolate supplementation and 1 week of placebo supplementation.
PlaceboDietary supplement
1 week of Non-whey protein Placebo supplement
| Study group | Role | What they receive |
|---|---|---|
| Whey Protein Supplementation | Experimental | Crossover study Receives: Dietary Supplement: Whey Protein Isolate Crossover |
| Placebo Supplementation | Placebo comparator | Crossover study Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7 days
Secondary outcomes (2)
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.
Measured: 7 days
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start15 Jan 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetes / Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will enroll 20 prediabetic (A1C 5.7%-6.4%) and 20 diabetic (A1C 6.5%-7.5%) subjects, 50-70 yrs of age, in randomized, crossover fashion. Each subject will participate in two 7d studies, with and without Whey Protein ingestion. Study order will be randomized. Subjects will consume their habitual diets (recorded by dietary log), with the dietary intervention being the additional consumption of two 30g doses of whey on the treatment assignment. Thirty grams of whey or placebo will be ingested within 1hr of waking and prior to breakfast, and a second 30g dose of WPI will be consumed 30min prior to the dinner meal. Main outcomes will be Matsuda index, 24hr glucose AUC, dietary intake (total kcal and macronutrients), and whole-body protein balance. The Matsuda index utilizes an oral glucose tolerance test to derive insulin sensitivity as assessed by euglycemic insulin clamp. Secondary outcomes will be satiety, satiation, and appetite score.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694155
- Sponsor's protocol ID
- 297495
- Acronym
- DAIRY
- Status last verified
- Apr 2026
- First submitted
- 15 Nov 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whey Protein Ingestion and Glucose Control in Pre- and Post Diabetic Individuals
- ClinicalTrials.gov ID
- NCT06694155
- Acronym / sponsor ID
- DAIRY / 297495
- Conditions
- Prediabetes / Type 2 Diabetes
- Keywords
- Whey Protein, type II diabetes, Protein turnover, Dietary intake
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Dairy Council
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals
Detailed description
Protein consumption in the morning has been shown to reduce appetite and caloric intake (19). In addition, premeal whey consumption reduces post prandial blood glucose, reduces gastric emptying rate, and increases peak blood insulin (10). Thus, it is proposed that ingestion of whey protein within 1hr of waking (and prior to breakfast) and 30 minutes prior to dinner will be more effective in suppressing appetite, carbohydrate intake, and glucose AUC. Ingestion upon waking will mitigate the cortisol-induced drive for carbohydrate intake. Ingestion prior to dinner, the most frequently consumed and largest meal in America (20), will reduce food intake, post meal blood glucose, and insulin area under the curve (21).
Specific Aims
- Determine the effect of WP ingestion within 1hr of waking and prior to breakfast, and 30min prior to dinner, on appetite suppression, carbohydrate and caloric intake, and 24hr glucose AUC over 7d in pre-diabetic (A1C 5.7%-6.4%) and diabetic (A1C 6.5%-7.5%) individuals.
- Determine the effect of WP ingestion within 1hr of waking and 30min prior to dinner on changes in OGTT, Matsuda index, and whole-body protein balance (compared to control) before and after 7d of WP consumption in pre-diabetic and diabetic individuals.
- Determine outcome differences between pre-diabetic and diabetic individuals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will enroll 20 prediabetic (A1C 5.7%-6.4%) and 20 diabetic (A1C 6.5%-7.5%) subjects, 50-70 yrs of age, in randomized, crossover fashion. Each subject will participate in two 7d studies, with and without Whey Protein ingestion. Study order will be randomized. Subjects will consume their habitual diets (recorded by dietary log), with the dietary intervention being the additional consumption of two 30g doses of whey on the treatment assignment. Thirty grams of whey or placebo will be ingested within 1hr of waking and prior to breakfast, and a second 30g dose of WPI will be consumed 30min prior to the dinner meal. Main outcomes will be Matsuda index, 24hr glucose AUC, dietary intake (total kcal and macronutrients), and whole-body protein balance. The Matsuda index utilizes an oral glucose tolerance test to derive insulin sensitivity as assessed by euglycemic insulin clamp. Secondary outcomes will be satiety, satiation, and appetite score.
| Arm | Type | Receives |
|---|---|---|
| Whey Protein Supplementation | Experimental | Dietary Supplement: Whey Protein Isolate CrossoverCrossover study |
| Placebo Supplementation | Placebo comparator | Dietary Supplement: PlaceboCrossover study |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey Protein Isolate CrossoverThis crossover intervention includes 1 week of whey protein isolate supplementation and 1 week of placebo supplementation. | Dietary supplement | Whey Protein Supplementation |
| Placebo1 week of Non-whey protein Placebo supplement | Dietary supplement | Placebo Supplementation |
Primary outcome
Whole body protein turnover
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
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.
2 secondary outcomes
Composite Appetite Scale
Time frame: 7 days
Dietary Intake Log
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein Isolate Crossover in people with Prediabetes / Type 2 Diabetes, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arny Ferrando, PhD (5015265711, aferrando@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body protein turnover (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.