- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02966444
Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition
July 24, 2018 updated by: Jada Stevenson, Texas Christian University
This study evaluates the effects of dietary fatty acid composition from high fat meals on markers of hunger, satiety and metabolism.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jada L Stevenson, PhD
- Phone Number: 817-257-6310
- Email: jada.stevenson@tcu.edu
Study Locations
-
-
Texas
-
Fort Worth, Texas, United States, 76102
- Recruiting
- Texas Christian University
-
Contact:
- Jada L Stevenson, PhD
- Phone Number: 817-257-6310
- Email: jada.stevenson@tcu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- BMI of >18.5-24.9kg/m2
- Woman
- 18-40yrs of age
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MUFA-rich HF Meal
High-fat meal rich in monounsaturated fatty acids
|
|
Experimental: PUFA-rich HF Meal
High-fat meal rich in polyunsaturated fatty acids
|
|
Experimental: SFA-rich HF Meal
High-fat meal rich in saturated fatty acids
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peptide-YY
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual Analog Scale
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jada L Stevenson, PhD, Texas Christian University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
July 1, 2018
Study Registration Dates
First Submitted
November 8, 2016
First Submitted That Met QC Criteria
November 15, 2016
First Posted (Estimate)
November 17, 2016
Study Record Updates
Last Update Posted (Actual)
July 26, 2018
Last Update Submitted That Met QC Criteria
July 24, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT2016JS1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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