Whey Protein Effects on Gycemic Control and Vascular Function

Effects of Pre-meal Whey Protein Ingestion on Daily Glycemic Control and Oxidative Stress Mediated Postprandial Inflammation and Vascular Dysfunction Evoked by Consumption of a High-glycemic Meal

Risk for heart and blood vessel diseases is increased when blood sugar rises. Blood vessel dysfunction is common to such diseases. Elevated blood sugar after eating promotes blood vessel dysfunction. Dietary factors other than carbohydrates influence rises and falls in blood sugar. Dietary protein is associated with improved blood sugar control. Whey protein effectively blunts the rise in blood sugar after consuming a carbohydrate rich drink/meal in normal weight and obese adults. This study will investigate the efficacy of drinking a whey protein beverage prior to eating for improved daily blood sugar control in normal weight and obese adults in the "real world." Also, the study will test this dietary approach to reduce blood vessel dysfunction associated with eating a meal that causes blood sugar to rise. 24 normal weight and 24 obese men and premenopausal women (18-50y) will participate. Subjects will wear a sensor to monitor daily blood sugar changes in response to their typically consumed diets for 2 days. Subjects will report to the UCLA CTRC the morning after the monitoring period for measurement of blood vessel function after eating a breakfast cereal meal. Blood samples will be obtained before and after the meal to measure relevant health markers. Subjects will repeat the 2-day diet and breakfast cereal meal challenge after a week or more, and will consume either a chocolate flavored 1) whey protein or 2) gelatin protein (control) shake prior to each meal. Neither subjects nor researchers will know which protein ("double blind"). Subjects will receive the alternate protein intervention after another week or more ("crossover"). We think drinking the protein shake prior to meals will reduce daily blood sugar rises and falls after eating and blunt the blood vessel dysfunction that results from eating the breakfast cereal.

Study Overview

• Status: Withdrawn
• Conditions: Blood Sugar (Glucose) Control; Blood Vessel (Vascular) Dysfunction
• Intervention / Treatment: Dietary supplement: Whey protein powder; Dietary supplement: Control protein

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18-50 years
• BMI between 18.5 and 25 or ≥ 30
• Willingness to provide written informed consent

Exclusion Criteria:

• Pregnant or breastfeeding currently or in prior 6 months
• Menopause in women
• Regular consumption of > 1 serving per day of milk/yogurt
• Known heart arrhythmia
• Use of tobacco products
• Any disease/pathological condition known to influence outcomes
• Use of medications/dietary supplements known to influence outcomes
• Recent or planned changes in diet/exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whey protein; Subjects on this arm will receive whey protein	Dietary supplement: Whey protein powder; Subjects on this arm will consume 20g whey protein powder mixed with water 15 minutes prior to breakfast, lunch, and dinner for two days
Active Comparator: Gelatin protein; Subjects on this arm will consume gelatin protein	Dietary supplement: Control protein; Subjects on this arm will consume 20g gelatin protein powder mixed with water 15 minutes prior to breakfast, lunch, and dinner for two days
No Intervention: Control arm; Subjects on this arm will receive no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average 24 hour glucose	The 24-hour glucose level (average of 48-hour monitoring period) for whey protein arm compared to other protein arm	48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Glycemic variability	48 hours
Post-meal percent change Brachial Artery Flow Mediated Dilation (FMD)	120 minutes
Post-meal monocyte inflammatory signaling	60 minutes
Post-meal percent change femoral artery blood flow (FBF)	120 minutes

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Anthony Thomas, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Estimated): March 1, 2015
• Study Completion (Estimated): March 1, 2015

Study Registration Dates

• First Submitted: March 15, 2013
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (Estimated): March 19, 2013

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Thomas whey 01