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

Last updated: February 20, 2025
Sponsor: University of Arkansas
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Placebo

Whey Protein Isolate Crossover

Clinical Study ID

NCT06694155
297495
  • Ages 50-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males and females ages 50-70 years.

  2. Capable of providing informed consent.

  3. COVID-19 negative and/or asymptomatic.

  4. Willing to abstain from drinking alcohol or consuming marijuana and CBD productsduring the 7-day study meal period on two occasions.

  5. HbA1c: 5.7-6.4% or 6.5% to 7.5%

Exclusion

Exclusion Criteria:

  1. Subject who does not/will not eat dairy protein sources.

  2. Subjects taking exogenous insulin injections or GLP /GIP injections or otherappetite 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 theresearch team.

  5. Lactose intolerance.

  6. Hemoglobin <10g/dL at screening.

  7. History of chemotherapy or radiation therapy for cancer in the 6 months prior toenrollment.

  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 findscontradictory to this study.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
January 15, 2025
Estimated Completion Date:
November 01, 2026

Study 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

  1. 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.

  2. 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.

  3. Determine outcome differences between pre-diabetic and diabetic individuals.

Connect with a study center

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.