ObesityNCT01506297
Biologic Assessment of Satiety
An observational study of Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
Subjective measures of satiety are correlated with biologic mechanisms of appetite control. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Aug 2014
- Phase
- Observational
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy men and women
Who may be able to join
- medical history (interview) demonstrating good health
- non-smoking
- not taking steroid-based medications
- not planning to or currently attempting to gain or lose weight
- being willing to consent to study conditions
- healthy adults ages 25-45 years
- body mass index between 18-30 kg/m2.
- University of North Dakota students may participate but student status is not required.
Who cannot join
- diagnosed eating disorders
- current or planned pregnancy
- lactation
- unmanaged hypertension (systolic >160 mmHg or diastolic > 100mmHg) and/or other cardiovascular, pulmonary, skeletal and metabolic diseases
- taking medications known to affect appetite, body composition, weight, or food intake
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Subjective measures of satiety are correlated with biologic mechanisms of appetite control.
- Conditions
- Obesity
- Keywords
- obesity, satiety, body weight management
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of subjective and objective satiety responses
Comparison of subjective responses and gut hormone responses of satiety
Measured: measures at -30, -15, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240, 300 minutes
Secondary outcomes (1)
Repeatability of subjective and objective measures of satiety
Repeated assessment (3 times) of subjective and objective responses to food intake
Measured: measures at -30, -15, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240, 300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan K Raatz, PhD, Principal investigator, USDA GFHNRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506297
- Sponsor's protocol ID
- GFHNRC504
- Status last verified
- Aug 2018
- First submitted
- 3 Jan 2012
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic Assessment of Satiety
- ClinicalTrials.gov ID
- NCT01506297
- Acronym / sponsor ID
- GFHNRC504
- Conditions
- Obesity
- Keywords
- obesity, satiety, body weight management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Jul 2012 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Jan 2012 (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.
Subjective measures of satiety are correlated with biologic mechanisms of appetite control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy men and women
Key inclusion criteria (8 listed)
- medical history (interview) demonstrating good health
- non-smoking
- not taking steroid-based medications
- not planning to or currently attempting to gain or lose weight
- being willing to consent to study conditions
Key exclusion criteria (5 listed)
- diagnosed eating disorders
- current or planned pregnancy
- lactation
- unmanaged hypertension (systolic >160 mmHg or diastolic > 100mmHg) and/or other cardiovascular, pulmonary, skeletal and metabolic diseases
- taking medications known to affect appetite, body composition, weight, or food intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of subjective and objective satiety responses
Time frame: measures at -30, -15, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240, 300 minutes
Comparison of subjective responses and gut hormone responses of satiety
1 secondary outcome
Repeatability of subjective and objective measures of satiety
Time frame: measures at -30, -15, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240, 300 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Susan K Raatz, PhD principal investigator
USDA GFHNRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by USDA Grand Forks Human Nutrition Research Center 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 3 Aug 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of subjective and objective satiety responses (time frame: measures at -30, -15, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240, 300 minutes). 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 3 Aug 2018.