Prediabetes / Type 2 Diabetes
Conditions
Keywords
Whey Protein, type II diabetes, Protein turnover, Dietary intake
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.
Interventions
DIETARY_SUPPLEMENTWhey Protein Isolate Crossover
This crossover intervention includes 1 week of whey protein isolate supplementation and 1 week of placebo supplementation.
DIETARY_SUPPLEMENTPlacebo
1 week of Non-whey protein Placebo supplement
Sponsors
University of Arkansas
National Dairy Council
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole body protein turnover | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite Appetite Scale | 7 days | 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. |
| Dietary Intake Log | 7 days | 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. |
Countries
United States
Contacts
CONTACTArny Ferrando, PhD
Outcome results
None listed