Whey Protein Effects on Gycemic Control and Vascular Func... | NCT01814358

Studies
Whey Protein Effects on Gycemic Control and Vascular Function

NCT01814358

Sponsor

University of California, Los Angeles

Status

Withdrawn

Last Update Posted

Oct 2, 2023Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

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

Interventions

Whey protein powder
Control protein

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Mar 2015Estimated

Completion Date

Mar 2015Estimated

First Submitted Date

Mar 15, 2013

First Submission Date that Met QC Criteria

Mar 15, 2013

First Posted Date

Mar 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2023

Last Update Posted Date

Oct 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Whey protein	Experimental	Subjects on this arm will receive whey protein	Dietary Supplement: Whey protein powder
Gelatin protein	Active Comparator	Subjects on this arm will consume gelatin protein	Dietary Supplement: Control protein
Control arm	No Intervention	Subjects on this arm will receive no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Whey protein powder	Dietary Supplement	Subjects on this arm will consume 20g whey protein powder mixed with water 15 minutes prior to breakfast, lunch, and dinner for two days	Whey protein

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Glycemic variability		48 hours
Post-meal percent change Brachial Artery Flow Mediated Dilation (FMD)		120 minutes
Post-meal monocyte inflammatory signaling

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anthony Thomas, PhD	University of California, Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA		Los Angeles	California	90095	United States