NCT06694155NARecruiting

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

University of Arkansas

Start Date

1/15/2025

Completion Date

3/1/2027

Summary

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 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.

Eligibility Criteria

Age Range: 50 years to 70 years

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.

Interventions

DIETARY_SUPPLEMENT

Whey Protein Isolate Crossover

DIETARY_SUPPLEMENT

Placebo

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Conditions

Prediabetes / Type 2 Diabetes

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas 72202

United States