Hunger, Satiety, and Metabolic Responses to High-fat Meal... | NCT02966444

Studies
Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition

NCT02966444

Sponsor

Texas Christian University

Status

Unknown status

Last Update Posted

Jul 26, 2018Actual

Enrollment

16Estimated

Phase

Not Applicable

Conditions

Body Weight Changes

Interventions

MUFA-rich HF Meal
PUFA-rich HF Meal
SFA-rich HF Meal

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Jul 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Nov 8, 2016

First Submission Date that Met QC Criteria

Nov 15, 2016

First Posted Date

Nov 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2018

Last Update Posted Date

Jul 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MUFA-rich HF Meal	Experimental	High-fat meal rich in monounsaturated fatty acids	Other: MUFA-rich HF Meal
PUFA-rich HF Meal	Experimental	High-fat meal rich in polyunsaturated fatty acids	Other: PUFA-rich HF Meal
SFA-rich HF Meal	Experimental	High-fat meal rich in saturated fatty acids	Other: SFA-rich HF Meal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MUFA-rich HF Meal	Other		MUFA-rich HF Meal
PUFA-rich HF Meal

Measure	Description	Time Frame
Peptide-YY		18 months

Measure	Description	Time Frame
Visual Analog Scale		18 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jada L Stevenson, PhD	Contact	817-257-6310		jada.stevenson@tcu.edu

Overall Officials

Name	Affiliation	Role
Jada L Stevenson, PhD	Texas Christian University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas Christian University	Recruiting	Fort Worth	Texas	76102	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms