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Whey Protein Effects on Gycemic Control and Vascular Function

NCT01814358 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-10-02

No results posted yet for this study

Summary

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.

Conditions

  • Blood Sugar (Glucose) Control
  • Blood Vessel (Vascular) Dysfunction

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Anthony Thomas, PhD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01814358 on ClinicalTrials.gov