Optimizing Meal and Snack Timing to Promote Health (S43)

January 9, 2018 updated by: Wayne Campbell, Purdue University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 + 20 g protein consumption
10 g breakfast followed by the consumption of a 20g whey protein shake
Dietary supplement: 10 + 20 g protein consumption
whey isolate
Active Comparator: 30 g protein breakfast
Other: 30 g protein breakfast
30 g mixed meal breakfast
Active Comparator: 10 g protein breakfast
Other: 10 g protein breakfast
10 g mixed meal breakfast

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimate)

July 23, 2015

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 1501015661

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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