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Whey Protein Effects on Gycemic Control and Vascular Function

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Anthony Thomas, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01814358
First received: March 15, 2013
Last updated: November 6, 2014
Last verified: November 2014

March 15, 2013
November 6, 2014
March 2013
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01814358 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Blood Sugar (Glucose) Control
  • Blood Vessel (Vascular) Dysfunction
  • 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
  • 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
  • Experimental: Whey protein
    Subjects on this arm will receive whey protein
    Intervention: Dietary Supplement: Whey protein powder
  • Active Comparator: Gelatin protein
    Subjects on this arm will consume gelatin protein
    Intervention: Dietary Supplement: Control protein
  • No Intervention: Control arm
    Subjects on this arm will receive no intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01814358
Thomas whey 01
No
Anthony Thomas, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Anthony Thomas, PhD University of California, Los Angeles
University of California, Los Angeles
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP