Optimizing Meal and Snack Timing to Promote Health | NCT02506218

Studies
Optimizing Meal and Snack Timing to Promote Health

NCT02506218

Sponsor

Purdue University

Status

Completed

Last Update Posted

Jan 12, 2018Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Dietary Modification

Interventions

10 + 20 g protein consumption
30 g protein breakfast
10 g protein breakfast

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

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Jun 24, 2015

First Submission Date that Met QC Criteria

Jul 21, 2015

First Posted Date

Jul 23, 2015Estimated

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

Jan 9, 2018

Last Update Posted Date

Jan 12, 2018Actual

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

This study will be conducted using standardized techniques to collect blood samples via an acute, randomized, cross-over design. Subjects will be provided all of their meals the day prior to testing and participate in 3 testing days with a minimum of 1 week break between testing days and a maximum time commitment of 7 weeks. A trained phlebotomist will place a catheter and collect blood samples from an antecubital vein using sterile techniques.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
10 + 20 g protein consumption	Experimental	10 g breakfast followed by the consumption of a 20g whey protein shake	Dietary Supplement: 10 + 20 g protein consumption
30 g protein breakfast	Active Comparator		Other: 30 g protein breakfast
10 g protein breakfast	Active Comparator		Other: 10 g protein breakfast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
10 + 20 g protein consumption	Dietary Supplement	whey isolate	10 + 20 g protein consumption

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma amino acid concentration	Peak plasma concentration of amino acids	7 weeks

Secondary Outcomes

Measure	Description	Time Frame
Blood glucose concentration	Area under the curve of blood glucose	7 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

25-39 years old

BMI between 22-37 kg/m2
Weight stable (± 4.5 kg) for the previous 3 months
Not currently (or within the past 6 months) following a vigorous exercise regimen or weight loss program
No acute illness
Not smoking
Not diabetic
Not pregnant or planning pregnancy in the next 3 months
Lactose tolerant
Willing to limit purposeful activity for 48 hours prior to each testing day
Willing to consume study foods and beverages.

Exclusion Criteria:

<25 or >39 years old, BMI <22 or >37 kg/m2
Currently (or within the past 6 months) following a vigorous exercise regimen greater than -3 - 45 minute exercise sessions per week
Currently following a weight loss program where subject has lost greater than 4.5 kg
Acute illness
Smoking
Diabetic
Pregnant or planning pregnancy in the next 3 months
Lactose intolerant
Unwilling to consume study foods and beverages
Peri and post-menopausal women.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided