Clinical trial NCT06694155: Whey Protein Ingestion and Glucose Control in Pre- and Post Diabetic Individuals
Official title: Whey Protein Ingestion and Glucose Control in Pre- and Post Diabetic Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetes / Type 2 Diabetes
Keywords: Whey Protein
type II diabetes
Protein turnover
Dietary intake
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Dairy Council
First posted: 2024-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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: 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 products during the 7-day study meal period on two occasions.
5. HbA1c: 5.7-6.4% or 6.5% to 7.5%

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.

Primary outcomes:
measure: Whole body protein turnover
timeFrame: 7 days
measure: Oral Glucose Tolerance Test
timeFrame: 7 days
measure: Blood glucose
timeFrame: 7 days
Secondary outcomes:
measure: Composite Appetite Scale
timeFrame: 7 days
measure: Dietary Intake Log
timeFrame: 7 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
References: