- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02259023
Discretionary Food Sources and Stress Perception
Purpose:
The objective of this study is to determine the effect different sources and forms of discretionary foods have on stress perception in healthy adults in a free living, real world setting.
Rationale:
The rationale for conducting this study is to test the effects of sugar-sweetened beverages and grain-based desserts have on perceived health and stress perception, since the evidence for this topic is limited.
Study Overview
Status
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55454
- University of Minnesota West Bank Office Building
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults who consume sugar sweetened beverages and grain based desserts and candy on a regular basis
- Free from major illnesses or chronic disease
- Willing to consume amount of beverages and food provided to supplement usual dietary habits during each period
Exclusion Criteria:
- Recently lost a significant amount or looking to lose weight
- Recently begun a new diet or exercise regimen
- Pregnant or nursing women
- Report restrained eater or having less than 51% control over food preparation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liquid: Sugar sweetened beverage consumption
Consumption of sugar-sweetened beverages
|
Sugar sweetened beverage consumption
Grain based desserts and candy consumption
|
Experimental: Solid: Grain based desserts and candy consumption
Consumption of grain based desserts and/or candy
|
Sugar sweetened beverage consumption
Grain based desserts and candy consumption
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress Perception
Time Frame: 12 weeks
|
A questionnaire adapted from the SF-12 will be used to measure stress perception.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Weight
Time Frame: 12 weeks
|
A digital scale will be used to measure body weight.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew Odegaard, Ph.D., University of Minnesota
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DFS2014
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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