Stress PerceptionNCT02259023
Discretionary Food Sources and Stress Perception
A study testing Liquid: Sugar sweetened beverage consumption and Solid: Grain based desserts and candy consumption in people with Stress Perception and Discretionary Calories, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Perception, Discretionary Calories, Over All Health
- What is being tested?
- Liquid: Sugar sweetened beverage consumption and Solid: Grain based desserts and candy consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota West Bank Office Building
Minneapolis, Minnesota, 55454
About this study
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.
- Conditions
- Stress Perception, Discretionary Calories, Over All Health
- Being tested
- Liquid: Sugar sweetened beverage consumption, Solid: Grain based desserts and candy consumption
- Keywords
- Stress Perception, Discretionary Calories, Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid: Sugar sweetened beverage consumptionOther
Sugar sweetened beverage consumption
Solid: Grain based desserts and candy consumptionOther
Grain based desserts and candy consumption
| Study group | Role | What they receive |
|---|---|---|
| Liquid: Sugar sweetened beverage consumption | Experimental | Consumption of sugar-sweetened beverages Receives: Other: Liquid: Sugar sweetened beverage consumption; Other: Solid: Grain based desserts and candy consumption |
| Solid: Grain based desserts and candy consumption | Experimental | Consumption of grain based desserts and/or candy Receives: Other: Liquid: Sugar sweetened beverage consumption; Other: Solid: Grain based desserts and candy consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress Perception
A questionnaire adapted from the SF-12 will be used to measure stress perception.
Measured: 12 weeks
Secondary outcomes (1)
Body Weight
A digital scale will be used to measure body weight.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress PerceptionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Odegaard, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259023
- Sponsor's protocol ID
- DFS2014
- Status last verified
- Oct 2017
- First submitted
- 29 Sep 2014
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discretionary Food Sources and Stress Perception
- ClinicalTrials.gov ID
- NCT02259023
- Acronym / sponsor ID
- DFS2014
- Conditions
- Stress Perception, Discretionary Calories, Over All Health
- Keywords
- Stress Perception, Discretionary Calories, Health
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liquid: Sugar sweetened beverage consumption | Experimental | Other: Liquid: Sugar sweetened beverage consumption, Other: Solid: Grain based desserts and candy consumptionConsumption of sugar-sweetened beverages |
| Solid: Grain based desserts and candy consumption | Experimental | Other: Liquid: Sugar sweetened beverage consumption, Other: Solid: Grain based desserts and candy consumptionConsumption of grain based desserts and/or candy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid: Sugar sweetened beverage consumptionSugar sweetened beverage consumption | Other | Liquid: Sugar sweetened beverage consumption, Solid: Grain based desserts and candy consumption |
| Solid: Grain based desserts and candy consumptionGrain based desserts and candy consumption | Other | Liquid: Sugar sweetened beverage consumption, Solid: Grain based desserts and candy consumption |
Primary outcome
Stress Perception
Time frame: 12 weeks
A questionnaire adapted from the SF-12 will be used to measure stress perception.
1 secondary outcome
Body Weight
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Odegaard, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid: Sugar sweetened beverage consumption and Solid: Grain based desserts and candy consumption in people with Stress Perception and Discretionary Calories, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Perception (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.