Optimizing Meal and Snack Timing to Promote Health

Dietary Modification Clinical Trial

— S43  

Official title:

Optimizing Meal and Snack Timing to Promote Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506218
• Other study ID #: 1501015661
• Status: Completed
• Phase: N/A
• First received: June 24, 2015
• Last updated: January 9, 2018
• Start date: April 2015
• Est. completion date: March 2016

Study information

• Verified date: January 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Modification

Intervention

Dietary Supplement:
• 10 + 20 g protein consumption
whey isolate

Other:
• 30 g protein breakfast
30 g mixed meal breakfast
• 10 g protein breakfast
10 g mixed meal breakfast

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma amino acid concentration	Peak plasma concentration of amino acids	7 weeks
Secondary	Blood glucose concentration	Area under the curve of blood glucose	7 weeks