Whey Protein Effects on Gycemic Control and Vascular Function

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Anthony Thomas, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01814358
First received: March 15, 2013
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Blood Sugar (Glucose) Control
Blood Vessel (Vascular) Dysfunction
Dietary Supplement: Whey protein powder
Dietary Supplement: Control protein
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Average 24 hour glucose [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    The 24-hour glucose level (average of 48-hour monitoring period) for whey protein arm compared to other protein arm


Secondary Outcome Measures:
  • Glycemic variability [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Post-meal percent change Brachial Artery Flow Mediated Dilation (FMD) [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
  • Post-meal monocyte inflammatory signaling [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Post-meal percent change femoral artery blood flow (FBF) [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01814358

Contacts
Contact: Anthony Thomas, PhD 310-825-8499 apthomas@ucla.edu
Contact: Kevin Nizi 310-825-8499

Locations
United States, California
UCLA Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Anthony Thomas, PhD    310-825-8499    apthomas@ucla.edu   
Contact: Evelyn Cholakians    310-825-8499      
Principal Investigator: Anthony Thomas, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Anthony Thomas, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Anthony Thomas, Post-doctoral researcher, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01814358     History of Changes
Other Study ID Numbers: Thomas whey 01
Study First Received: March 15, 2013
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014