Overview

This trial is active, not recruiting.

Condition dietary modification
Treatments 10 + 20 g protein consumption, 30 g protein breakfast, 10 g protein breakfast
Sponsor Purdue University
Start date April 2015
End date March 2016
Trial size 18 participants
Trial identifier NCT02506218, 1501015661

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
10 g breakfast followed by the consumption of a 20g whey protein shake
10 + 20 g protein consumption
whey isolate
(Active Comparator)
30 g protein breakfast
30 g mixed meal breakfast
(Active Comparator)
10 g protein breakfast
10 g mixed meal breakfast

Primary Outcomes

Measure
Plasma amino acid concentration
time frame: 7 weeks

Secondary Outcomes

Measure
Blood glucose concentration
time frame: 7 weeks

Eligibility Criteria

Male or female participants from 25 years up to 39 years old.

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.

Additional Information

Official title Optimizing Meal and Snack Timing to Promote Health
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Purdue University.