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

NCT06694155 | Recruiting

• 1 other identifier: 297495
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prediabetes / Type 2 Diabetes

Keywords

Whey Protein; type II diabetes; Protein turnover; Dietary intake

Outcome Measures

Primary Outcomes (3)

• Whole body protein turnover

  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.

  7 days

• Oral Glucose Tolerance Test

  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.

  7 days

• Blood glucose

  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.

  7 days

Secondary Outcomes (2)

• Composite Appetite Scale

  7 days

• Dietary Intake Log

  7 days

Study Arms (2)

Whey Protein Supplementation

EXPERIMENTAL

Crossover study

Dietary Supplement: Whey Protein Isolate Crossover

Placebo Supplementation

PLACEBO COMPARATOR

Crossover study

Dietary Supplement: Placebo

Interventions

Whey Protein Isolate Crossover DIETARY_SUPPLEMENT

This crossover intervention includes 1 week of whey protein isolate supplementation and 1 week of placebo supplementation.

Whey Protein Supplementation

Placebo DIETARY_SUPPLEMENT

1 week of Non-whey protein Placebo supplement

Placebo Supplementation

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ages 50-70 years.
• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead
• National Dairy Council: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72202, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Arny Ferrando, PhD

CONTACT

5015265711; aferrando@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-05

Locations

US (1)