Recruiting

Whey Protein

Sponsor:

University of Arkansas

Code:

NCT06694155

Conditions

Prediabetes / Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Not accepted

Interventions

Whey Protein Isolate Crossover

Placebo

Study Details

Brief summary:

To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals

Conditions

Prediabetes / Type 2 Diabetes

Study ID

NCT06694155

Start date

Jan 15, 2025

Status verified date

Apr, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Whey Protein Supplementation

Crossover study

placebo comparator: Placebo Supplementation

Crossover study

Interventions

Whey Protein Isolate Crossover

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

Placebo

1 week of Non-whey protein Placebo supplement

Primary outcome measure

  • Whole body protein turnover [ Time Frame: 7 days ]
  • Oral Glucose Tolerance Test [ Time Frame: 7 days ]
  • Blood glucose [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

More Information

Sponsor

University of Arkansas

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Keywords

  • Whey Protein
  • type II diabetes
  • Protein turnover
  • Dietary intake

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2026-04-06.