Body Weight ChangesNCT02966444
Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition
A study testing MUFA-rich HF Meal, PUFA-rich HF Meal and SFA-rich HF Meal in people with Body Weight Changes, run by Texas Christian University at 1 site in United States.
Trial summary
This study evaluates the effects of dietary fatty acid composition from high fat meals on markers of hunger, satiety and metabolism. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- MUFA-rich HF Meal, PUFA-rich HF Meal and SFA-rich HF Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jul 2018
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of >18.5-24.9kg/m2
- Woman
- 18-40yrs of age
Who cannot join
- Evidence of weight loss or gain exceeding 5% of their body weight within the past 3 months.
- Plans to lose weight or begin a weight loss program between initiation of study and final testing.
- Plans to begin an exercise program or change current exercise routines between initiation of study and final testing.
- Is on a medically prescribed diet
- Does not consume breakfast regularly
- Rate less than 80% of foods offered in the buffet at 50mm or more on the 100mm VAS as palatable
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- Medications that could influence appetite or sensory function
- Reports of metabolic or endocrine disease, gastrointestinal disorders, or history of medical or surgical events that could affect fat digestion and hormone signaling.
- Any chronic disease including type II diabetes, hypothyroidism, hyperthyroidism, cardiovascular disease, and cancer
- Any supplements that a subject begins taking between initiation of study and final testing.
- Anyone who is currently pregnant, lactating, or planning on becoming pregnant before the conclusion of this study.
- Anyone who has allergies to any of the components of the liquid meals
- Anyone who has donated blood in the last 20 days
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Christian University
Fort Worth, Texas, 76102
Jada L Stevenson, PhD, 817-257-6310, jada.stevenson@tcu.edu
About this study
This study evaluates the effects of dietary fatty acid composition from high fat meals on markers of hunger, satiety and metabolism.
- Conditions
- Body Weight Changes
- Being tested
- MUFA-rich HF Meal, PUFA-rich HF Meal, SFA-rich HF Meal
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUFA-rich HF MealOther
PUFA-rich HF MealOther
SFA-rich HF MealOther
| Study group | Role | What they receive |
|---|---|---|
| MUFA-rich HF Meal | Experimental | High-fat meal rich in monounsaturated fatty acids Receives: Other: MUFA-rich HF Meal |
| PUFA-rich HF Meal | Experimental | High-fat meal rich in polyunsaturated fatty acids Receives: Other: PUFA-rich HF Meal |
| SFA-rich HF Meal | Experimental | High-fat meal rich in saturated fatty acids Receives: Other: SFA-rich HF Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peptide-YY
Measured: 18 months
Secondary outcomes (1)
Visual Analog Scale
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jada Stevenson, Texas Christian University
- Investigators
- Jada L Stevenson, PhD, Principal investigator, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966444
- Sponsor's protocol ID
- CT2016JS1
- Status last verified
- Jul 2018
- First submitted
- 8 Nov 2016
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition
- ClinicalTrials.gov ID
- NCT02966444
- Acronym / sponsor ID
- CT2016JS1
- Conditions
- Body Weight Changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 17 Nov 2016 (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.
This study evaluates the effects of dietary fatty acid composition from high fat meals on markers of hunger, satiety and metabolism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MUFA-rich HF Meal | Experimental | Other: MUFA-rich HF MealHigh-fat meal rich in monounsaturated fatty acids |
| PUFA-rich HF Meal | Experimental | Other: PUFA-rich HF MealHigh-fat meal rich in polyunsaturated fatty acids |
| SFA-rich HF Meal | Experimental | Other: SFA-rich HF MealHigh-fat meal rich in saturated fatty acids |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI of >18.5-24.9kg/m2
- Woman
- 18-40yrs of age
Key exclusion criteria (13 listed)
- Evidence of weight loss or gain exceeding 5% of their body weight within the past 3 months.
- Plans to lose weight or begin a weight loss program between initiation of study and final testing.
- Plans to begin an exercise program or change current exercise routines between initiation of study and final testing.
- Is on a medically prescribed diet
- Does not consume breakfast regularly
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 |
|---|---|---|
| MUFA-rich HF Meal | Other | MUFA-rich HF Meal |
| PUFA-rich HF Meal | Other | PUFA-rich HF Meal |
| SFA-rich HF Meal | Other | SFA-rich HF Meal |
Primary outcome
Peptide-YY
Time frame: 18 months
1 secondary outcome
Visual Analog Scale
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 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.
Jada L Stevenson, PhD principal investigator
Texas Christian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MUFA-rich HF Meal, PUFA-rich HF Meal and SFA-rich HF Meal in people with Body Weight Changes, run by Texas Christian University 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 13 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: status not confirmed, as of the sponsor's last update on 26 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jada L Stevenson, PhD (817-257-6310, jada.stevenson@tcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peptide-YY (time frame: 18 months). 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 Jul 2018.