Whey Protein Ingestion and Glucose Control in Pre- and Post Diabetic Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whey Protein Isolate Crossover, Placebo.
- Who it may be relevant to
- Registry conditions: Prediabetes / Type 2 Diabetes. Basic parameters: 50 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 supplement Whey Protein Isolate Crossover
This crossover intervention includes 1 week of whey protein isolate supplementation and 1 week of placebo supplementation. - Dietary supplement Placebo
1 week of Non-whey protein Placebo supplement
Primary outcome measures
- Whole body protein turnover [Time frame: 7 days]
- Oral Glucose Tolerance Test [Time frame: 7 days]
- Blood glucose [Time frame: 7 days]
Secondary outcome measures (2)
- Composite Appetite Scale [Time frame: 7 days]
- Dietary Intake Log [Time frame: 7 days]
Eligibility criteria
Inclusion criteria
- Males and females ages 50-70 years.
- Body mass index between 25-45 kg/m2
- Capable of providing informed consent.
- COVID-19 negative and/or asymptomatic.
- Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 7-day study meal period on two occasions.
- HbA1c: 5.7-6.4% or 6.5% to 7.5% or fasting glucose ≥100 mg/dL
Exclusion criteria
- Subject who does not/will not eat dairy protein sources.
- Subjects taking exogenous insulin injections or GLP /GIP injections or other appetite suppressants.
- Unwilling to keep a detailed 7 day food journal on two occasions
- Unwilling to wear a CGM for 7 days on two occasions and share the data with the research team.
- Lactose intolerance.
- Hemoglobin <10g/dL at screening.
- History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
- History of gastrointestinal bypass/reduction surgery.
- Pregnant or lactating individuals.
- History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)
- Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
- Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).
- Unwilling to avoid using protein or amino-acid supplements during participation.
- Unwilling to fast overnight.
- Any medical condition or medication that the PI or clinical study staff finds contradictory to this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Arkansas for Medical Sciences — Little Rock
Identifiers
NCT: NCT06694155 · 297495